Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

 has accepted the Biologics License Application (BLA) for lonvoguran ziclumeran (lonvo-z) and granted it priority review for hereditary angioedema (HAE) in patients aged ≥ 16 years, setting a Prescription Drug User Fee Act (PDUFA) target action date of March 10, 2027, according to Intellia Therapeutics.¹

If approved, lonvo-z would become the first in vivo CRISPR-based therapy to reach the HAE market and the only one-time treatment option available to patients who currently manage the disease with chronic intravenous or subcutaneous prophylaxis. FDA has indicated it does not currently plan to convene an advisory committee to review the application.¹ The filing follows a phase 3 program in which the global HAELO trial enrolled 80 patients in 9 months.¹

"Today's announcement is exciting because it advances us one step closer to potentially having a one-time treatment option available for patients who continue to be burdened by this chronic disease,” said HAELO trial investigator Joshua Jacobs, MD, medical director of Allergy and Asthma Clinical Research, in a statement. ¹

Lonvo-z HAELO Trial Design and Primary Efficacy Results

The BLA is supported by data from the phase 3 HAELO trial, a global study evaluating a one-time 50 mg dose of lonvo-z in adults and adolescents aged ≥ 16 years with type 1 or type 2 HAE.² HAELO met its primary endpoint and all key secondary endpoints.

Lonvo-z produced an 87% reduction in mean monthly attacks compared with placebo during the efficacy evaluation period spanning weeks 5 through 28 (

 <.0001).² The KLKB1 gene-editing mechanism is designed to permanently lower plasma kallikrein activity following a single outpatient infusion.² Intellia frames the result as the clinical basis for a durable, one-time alternative to prophylaxis regimens administered as often as twice weekly or daily.²

Lonvo-z Secondary Endpoints and Safety Profile


Lonvo-z (lonvoguran ziclumeran) is under FDA Priority Review as a one-time in vivo CRISPR gene-editing treatment for hereditary angioedema in patients 16 years and older with type 1 or type 2 disease.


Lonvo-z uses CRISPR/Cas9 in vivo gene editing to inactivate the KLKB1 gene, permanently lowering plasma kallikrein activity after a single outpatient infusion.


The phase 3 HAELO trial showed an 87% reduction in mean monthly HAE attacks with lonvo-z versus placebo (

 <.0001), with 62% of treated patients entirely attack-free and therapy-free through 6 months.

Secondary results reinforced the primary finding. In the lonvo-z arm, 62% of patients remained entirely attack-free and free of HAE therapy for the 6-month efficacy evaluation period, compared with 11% of patients receiving placebo (

 <.0001).¹ As of the February 10, 2026 data cutoff, all patients who received lonvo-z at baseline or crossed over after week 28 remained free from long-term prophylaxis therapy.¹

The safety profile was favorable through the data cutoff, according to Intellia.¹ Treatment emergent adverse events more common in the lonvo-z group than placebo included infusion-related reactions, headache, fatigue, back pain, and upper respiratory tract infection.¹ The company reported all treatment emergent adverse events as mild or moderate, with no serious adverse events observed in the lonvo-z arm.¹

Lonvo-z has received 5 regulatory designations to date, including Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) designations from FDA, Innovation Passport designation from the UK Medicines and Healthcare products Regulatory Agency, Priority Medicines designation from the European Medicines Agency, and Orphan Drug Designation from the European Commission.¹

"Today marks an important milestone for the patients we are committed to serving and for Intellia's pioneering work in the field of in vivo gene editing," said John Leonard, MD, president and chief executive officer at Intellia Therapeutics, in a statement.

"Backed by compelling phase 3 data, we believe lonvo-z could fundamentally change the way HAE is treated and are excited by its potential to become the world's first approved in vivo CRISPR-based therapy."¹

Intellia Therapeutics announces FDA acceptance of Biologics License Application with Priority Review for lonvoguran ziclumeran (lonvo-z) for hereditary angioedema (HAE). Published September 8, 2026. Intellia Therapeutics. Accessed September 8, 2026. 

https://www.globenewswire.com/news-release/2026/09/08/3357599/0/en/intellia-therapeutics-announces-fda-acceptance-of-biologics-license-application-with-priority-review-for-lonvoguran-ziclumeran-lonvo-z-for-hereditary-angioedema-hae.html

Banerji A. Single-Dose Lonvo-z Cuts HAE Attacks by 87% in Phase 3 Trial, With Aleena Banerji, MD. HCPLive. Published April 27, 2026. Accessed September 8, 2026. 

https://www.hcplive.com/view/single-dose-lonvo-z-cuts-hae-attacks-87-phase-3-trial-aleena-banerji-md

Articles

FDA accepted the BLA for lonvoguran ziclumeran (lonvo-z) for hereditary angioedema in patients aged ≥16 years and granted priority review, with a PDUFA date of March 10, 2027. The one-time, in vivo CRISPR therapy targets KLKB1 to durably reduce plasma kallikrein activity after a single outpatient infusion. Phase 3 HAELO enrolled 80 patients in 9 months and met primary and key secondary endpoints, showing substantial attack reduction and high attack-free rates, with a favorable safety profile.

The FDA granted lonvo-z priority review for HAE, setting a PDUFA date of March 10, 2027 based on positive Phase 3 HAELO data.

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FDA News

Lonvo-z BLA Accepted by FDA With Priority Review for HAE

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

Image Credit: US Food and Drug Administration

 has approved Abbott's TactiFlex Duo Ablation Catheter, Sensor Enabled, for treating patients with 

TactiFlex Duo Ablation Catheter, Sensor Enabled is FDA-approved to treat patients with atrial fibrillation, including complex cases involving challenging anatomy or prior failed ablation.

The catheter delivers pulsed field ablation, radiofrequency energy, or both from a single flexible-tip device, letting physicians create therapeutic lesions to block the abnormal electrical signals driving AFib.

At twelve months, 74.6% of patients were free from documented arrhythmia recurrence, medication changes, or repeat procedures, with a primary safety endpoint event rate of 1.7%.

Announced by the company on September 8, 2026, the approval rests on 12-month results from the FlexPulse investigational device exemption (IDE) study, presented as late-breaking data at the European Society of Cardiology (ESC) Congress 2026 and published simultaneously in EP Europace. Abbott plans to expand commercial availability of the catheter across the United States in the coming weeks.

“Electrophysiology is rapidly evolving as physicians adopt new technologies that improve the safety and effectiveness of AFib treatment,” Atul Verma, MD, director of cardiology at the McGill University Health Center in Montreal, said in a statement. “TactiFlex Duo provides physicians with greater flexibility during procedures, and when it is combined with the high-resolution 3D visualization available through Abbott’s EnSite X mapping system, physicians have a suite of practice-changing tools to confidently treat patients with complex AFib.”

The approval gives US electrophysiologists a single catheter capable of delivering PFA, RF energy, or both within one procedure rather than requiring separate tools for each modality. Abbott markets the device for patients with complex anatomy or prior failed ablation, a population operators often manage with longer or staged procedures.

The FlexPulse IDE study was a prospective, multicenter, single-arm, nonrandomized trial designed to support US approval of TactiFlex Duo. Investigators enrolled patients with symptomatic, recurrent, drug-refractory paroxysmal AFib between November 2024 and April 2025. Pulmonary vein isolation was achieved in all 180 study participants using the dual-energy catheter.

At 12 months, the study met its primary effectiveness endpoint, with 74.6% of patients remaining free from documented arrhythmia recurrence, antiarrhythmic medication changes, or repeat ablation procedures. 2 secondary monitoring analyses reinforced the primary result: 92.6% of patients had no documented recurrence of AFib, atrial flutter, or atrial tachycardia under standard-of-care monitoring, while 77.4% remained recurrence-free under more intensive protocol-driven monitoring.

TactiFlex Duo safety profile and EnSite X integration

The primary safety endpoint event rate in FlexPulse was 1.7%, and Abbott reported no major safety signals through twelve months of follow-up. The company also noted that the safety profile was consistent across sites and energy modalities used during the study.

TactiFlex Duo integrates with Abbott's EnSite X EP System, which layers three-dimensional cardiac mapping with the PFA Index, a feature designed to give operators real-time feedback on lesion formation as pulsed field energy is delivered.

Additional integration with the Advisor HD Grid X mapping catheter and the ViewFlex X intracardiac echocardiography catheter is intended to provide real-time catheter position and tissue-contact data during ablation. Abbott positions the combined mapping, imaging, and dual-energy ablation platform as suited to physicians managing anatomically complex AFib cases or procedures complicated by prior failed ablation.

“TactiFlex Duo represents an important advancement as Abbott builds the industry’s most comprehensive electrophysiology portfolio,” Uri Yaron, senior vice president of electrophysiology at Abbott, said in a statement. “By continuing to expand our PFA portfolio and integrate innovative technologies across cardiovascular care, we're helping physicians navigate increasingly complex procedures while ensuring more patients receive the right care at the right time."

Abbott said TactiFlex Duo extends a broader electrophysiology portfolio spanning diagnosis, mapping, intracardiac imaging, and ablation. The approval follows 2025 US and European clearances for the Volt PFA System and adds to a series of PFA-related approvals the company has secured across the United States, Europe, Asia, and Latin America over the past year.

Abbott. Abbott receives FDA approval for its TactiFlex Duo Ablation Catheter to treat people with abnormal heart rhythms. September 8, 2026. Accessed September 8, 2026. 

https://abbott.mediaroom.com/2026-09-08-Abbott-receives-FDA-approval-for-its-TactiFlex-TM-Duo-Ablation-Catheter-to-treat-people-with-abnormal-heart-rhythms

Hussein AA, Rackauskas G, Sundaram S, Piccini JP, Roithinger FX, Tung P, Osorio J, Colley BJ 3rd, Siddiqui UR, Lakkireddy DR, Chinitz LA, Hyman MC, Zitella Verbick L, Dirckx N, Woods V, Lo M; and the FlexPulse Investigators. Safety and Effectiveness of a Novel Dual-Energy Radiofrequency/Pulsed Field Ablation Catheter: 12 Month Results of the FlexPulse Study. Europace. 2026 Aug 29:euag238. 

Abbott received FDA approval for the TactiFlex Duo sensor-enabled ablation catheter for atrial fibrillation, including complex cases, supported by 12‑month FlexPulse IDE data presented at ESC 2026 and published in *Europace*. The dual-energy catheter enables pulsed field ablation (PFA), radiofrequency (RF), or combined use within a single procedure, aimed at anatomically challenging or redo ablations. In 180 patients with drug-refractory paroxysmal AF, pulmonary vein isolation was achieved universally, with 74.6% meeting the primary effectiveness endpoint and a 1.7% primary safety event rate.

Abbott's dual-energy PFA/RF ablation catheter met its primary effectiveness and safety endpoints in the 12-month FlexPulse IDE study behind its FDA nod.

Arrhythmia

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

TactiFlex Duo Ablation Catheter Receives FDA Approval for AFib

Ross M. Levy, MD, serves as a dermatologist at Endeavor Health in Illinois, specializing in cosmetic and surgical dermatology with expertise in Mohs surgery for skin cancer.

Skin Angels, the dermatology-focused angel investing network featured in a 

 panel, has evaluated more than 300 companies, with a portfolio spanning over-the-counter products, pharmaceuticals, and medical devices.¹ The group positions itself as more than a source of capital, pairing check-writing with clinicians who lend hands-on experience to founders navigating regulatory and commercial hurdles.

Members help move ideas from concept toward a minimum viable product and beyond, offering perspective and hands-on experience few venture networks outside dermatology can provide. Panelists noted an idea often starts as a simple pain point a clinician sees in daily practice, well before it becomes a formal business plan. Dermatology remains one of few specialties without an investment network solely dedicated to skin-focused innovation.

Venture investment in artificial intelligence within 

 has accelerated over the past decade, reshaping both clinical workflows and how lean a startup team needs to be to launch a new therapy.² A wave of startups is also harnessing specific areas of the immune system in topical formulations, aiming for targeted results with lower systemic risk to patients. Ross Levy, MD, a dermatologist at Endeavor Health specializing in cosmetic and surgical dermatology, discussed these shifts alongside fellow panelists Manju Dawkins, MD, Buu Duong, MD, Peter Lio, MD, and Ross Lane Pearlman, MD.

In the following Q&A interview, Levy spoke with 

 at LEADderm 2026 in Newport Beach, California, about the Skin Angels model, practical advice for early-career dermatologists, and where he expects dermatology innovation to head next:

: Is Skin Angels the first dermatology-focused angel investing group, and can you describe it?

Sure. We're a loosely connected, affiliated group of dermatologists and people in industry interested in dermatology, really anybody who wants to learn more and develop skills with respect to investing in early-stage companies, which is what angel investing is. We're not just composed of people writing checks. We also have a group of people who lend their experience, since industry sometimes needs partners to improve or understand the clinician experience. We're trying to make it more than just an angel group, more of a real community of people who invest in and support the next generation of companies, but also help them get from the idea stage to the actual MVP stage and beyond, as well as act as a resource within dermatology. There are a number of these groups around, but none are solely focused on skin and dermatology, and there's a ton of innovation occurring in our field. That's kind of where we wanted the offering to land.

: What's one practical step a resident or early-career dermatologist can take to help shape the field rather than just follow it?

 I love the idea stage. We all have ideas, right? Essentially, an idea, when it comes to a business or a startup, is just a solution to a problem, a pain point we have or somebody else has had. Many times that idea is the result of a simple pain point, and many of us just chalk it up and move on with the rest of our day. What I hope is people say, I'm here at the front lines in medicine, there's a problem I see, it's either a problem for me or a problem for my patients, and I have a way to solve it and help out the world and my community. Those ideas are important, that's how these things start. Certainly there's a huge way to go between having an idea and a successful product and company, but it's got to start somewhere, and we want to position ourselves as a place where people can bring those ideas and move them forward, as well as see companies that have had those ideas and support them.

: Looking ahead, what do you hope to see from the next generation of dermatology innovators in 5 to 10 years?

That's a great question. Obviously AI is the tool everybody is talking about, specifically how it integrates and makes current practices quicker, faster, and better. There's a whole area of improving clinical efficiency and day-to-day work and administration, but there's also another area of increasing our ability to develop new chemicals and new treatments, and I think that's going to accelerate this process. The role of AI in shaping and moving companies forward is amazing too. What used to require 10 people to start an idea and a company can now be very lean, with one or two people getting it started. I'm really interested to see how AI and machine learning shape the industry in both of those areas. From a particular standpoint within dermatology, I'm excited about how there are so many new developments related to the immune system. You see a lot of startups now harnessing certain areas of the immune system in a fashion that's topical, so there's less risk to the patient, but the treatment is still very directed, and we still get good results.

Editor's Note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Levy had no relevant disclosures of note outside of his own involvement in Skin Angels.

Lio P. Skin Angels and the atopic dermatitis pipeline, with Peter Lio, MD. HCPLive. Published August 31, 2026. Accessed September 4, 2026. 

https://www.hcplive.com/view/skin-angels-atopic-dermatitis-pipeline-peter-lio-md

Ramachandran V, Jairath NK, Orlow SJ. A Decade of Venture Investment in Artificial Intelligence in Dermatology Amidst Macroeconomic Shifts and Technological Advancements. J Invest Dermatol. 2024;144(8):1685-1688.e1. doi:10.1016/j.jid.2024.02.024.

Skin Angels is a dermatology-centered angel network that combines early-stage capital with clinician-driven operational support to help founders navigate regulatory, product development, and commercialization milestones. With more than 300 companies evaluated across OTC products, pharmaceuticals, and devices, the group aims to formalize a community where frontline clinical pain points can be translated into minimum viable products and scalable businesses. Near-term innovation tailwinds include accelerating AI adoption to improve clinical efficiency and compress startup headcount, alongside topical, immune-targeted therapeutics designed to deliver directed efficacy with reduced systemic risk.

Ross Levy, MD, on how Skin Angels invests in dermatology innovation and where he sees the field heading over the next 5 - 10 years.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

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 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

How Skin Angels Backs Dermatology's Next Innovators, With Ross Levy, MD

Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

Semaglutide was associated with up to a 40% reduction in 

 attacks and a 20% reduction in chronic obstructive pulmonary disease (COPD) flare-ups compared with sulfonylureas in a real-world analysis of UK electronic health records presented at the 

European Respiratory Society (ERS) Congress 2026

 in Barcelona, Spain, held September 5 to 9.

GLP-1 receptor agonists are widely used to treat type 2 diabetes and obesity, both common comorbidities in asthma and COPD, increasing the risk of exacerbations, according to the study investigators.

 Prior observational research has suggested GLP-1 receptor agonists may have anti-inflammatory effects and improve lung-related outcomes, but the comparative effectiveness of newer versus older agents, the impact of dose, and any differential response between asthma and COPD had not been described.

“The effect was strongest with semaglutide, especially in people with asthma, where use of semaglutide appears to be associated with nearly 40% reduction in asthma attacks,” said Chloe Bloom, MD, PhD, clinical associate professor in respiratory epidemiology at the National Heart & Lung Institute, Imperial College London, who led the study.

 “Semaglutide also led to a 20% reduction in COPD flare-ups.”

How did semaglutide reduce airway exacerbations?

Using UK electronic medical records, investigators conducted 4 parallel new-user, active-comparator studies comparing initiators of each GLP-1 receptor agonist, semaglutide, liraglutide, dulaglutide, and exenatide, with initiators of sulfonylureas, another class of diabetes medication.

 Doubly robust inverse probability of treatment weighting was applied to control for confounding factors, including disease severity, body mass index, smoking status, eosinophil count, and comorbidities, and weighted hazard ratios were calculated for airway exacerbations.

 Investigators also assessed effect modification by GLP-1 receptor agonist dose and underlying respiratory condition, asthma or COPD.

In the semaglutide new-user cohort (n = 22,537), semaglutide initiation was associated with fewer airway exacerbations compared with sulfonylureas (weighted hazard ratio [wHR], 0.76; 95% CI, 0.60-0.96).

 The association was stronger at higher doses, with a wHR of 0.75 (95% CI, 0.58-0.95) at low doses and 0.28 (95% CI, 0.08-1.01) at medium or high doses, and was more pronounced in asthma (wHR, 0.20; 95% CI, 0.05-0.78) than in COPD (wHR, 0.76; 95% CI, 0.58-1.00).

Were effects more asthma-specific and drug-specific?

No significant associations with airway exacerbations were observed for liraglutide, dulaglutide, or exenatide, regardless of dose or underlying lung disease, despite similarly sized new-user cohorts for each individual agent.

 Investigators said only semaglutide showed a significant reduction in airway exacerbations, with evidence of a dose-response relationship and an association substantially stronger in asthma than in COPD.

In a real-world UK electronic health record study, semaglutide initiation was associated with a weighted hazard ratio of 0.20 for exacerbations in patients with asthma, corresponding to a nearly 40% reduction, compared with sulfonylureas.

Do other GLP-1 receptor agonists reduce airway exacerbations?

No. Liraglutide, dulaglutide, and exenatide showed no significant association with airway exacerbations, regardless of dose or underlying lung disease.

Should patients with asthma or COPD start a GLP-1 receptor agonist for their lung condition?

No. The study's lead investigator cautioned people with asthma or COPD against starting GLP-1 receptor agonists specifically for their lung condition outside current prescribing guidance, noting the findings need confirmation in clinical trials.

Each GLP-1 receptor agonist cohort included between roughly 20,000 and 22,000 new users compared against sulfonylurea initiators, and investigators applied the same weighting methodology across all 4 comparisons.

 Investigators said the differential findings across agents highlight the value of studying individual GLP-1 receptor agonists separately rather than as a single drug class, and asthma comorbidity may help guide GLP-1 receptor agonist selection in patients managed for diabetes and obesity.

“This is one of the largest real-world studies to investigate GLP-1 receptor agonists and airways disease, and one of the first to examine whether effects differ between individual GLP-1 receptor agonists,” said Alexander Mathioudakis, MD, PhD, chair of the European Respiratory Society Group on Airway Pharmacology and Treatment and senior lecturer in respiratory medicine at the University of Manchester, who was not involved in the research.

 “It highlights the need to consider metabolic health as part of respiratory care.”

Bloom cautioned the findings should not change treatment decisions on their own, noting people with asthma or COPD should not start GLP-1 receptor agonists specifically for their lung condition outside current prescribing guidance.

 Investigators described the analysis as one of the largest real-world studies of GLP-1 receptor agonists and airways disease, and said the results support including respiratory outcomes, such as asthma attacks and COPD exacerbations, in future trials of metabolic therapies.

Lee B, Cahill K, Bloom C. The differential effects of GLP-1 based therapies in airways disease. Presented at: European Respiratory Society (ERS) Congress 2026; September 5-9, 2026; Barcelona, Spain.

European Respiratory Society. Weight loss injection semaglutide can reduce asthma attacks by up to 40 per cent. Published September 8, 2026. Accessed September 8, 2026. 

https://www.ersnet.org/news-and-features/news/weight-loss-injection-semaglutide-can-reduce-asthma-attacks-by-up-to-40-per-cent/

Semaglutide initiation was linked to fewer airway exacerbations versus sulfonylureas in UK real-world data, with the largest relative reductions observed for asthma attacks (up to ~40%) and more modest reductions for COPD flare-ups (~20%). The association appeared dose-responsive and substantially stronger in asthma than COPD. Other GLP-1 receptor agonists (liraglutide, dulaglutide, exenatide) showed no significant exacerbation signal despite similar cohort sizes and identical analytic methods. Findings are hypothesis-generating and support prospectively capturing respiratory endpoints in metabolic-therapy trials.

Semaglutide was linked to fewer asthma attacks and COPD flare-ups than sulfonylureas, with no effect seen for other GLP-1 therapies.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

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COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

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Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

Semaglutide Cuts Asthma Attacks by up to 40% in Real-World Study

Jacqueline Ross, MD, a physician at Allergy Partners of New Jersey.

Michael Wechsler, MD, of National Jewish Health.

"Positioning Biologics in Asthma: GINA Step 5 and Earlier Treatment" takes up where these agents sit today, and where the panel thinks they belong.

Positioning Biologics in Asthma: GINA Step 5 and Earlier Treatment

Dr. Chupp asks Dr. Hanania whether biologics remain reserved for the most severe patients or are moving earlier. Dr. Hanania starts from evidence and guidelines. The evidence sits at GINA Step 5, because that is the population enrolled in the trials he has run for years: patients with exacerbations and high biomarker profiles, studied by indication across allergic, eosinophilic, steroid-dependent, and severe asthma.

Before any biologic, he insists on documentation. Many patients are referred as severe asthma but have uncontrolled disease, or no asthma at all, sending him back to square one. Severe means high-dose ICS plus LABA plus another bronchodilator with continued symptoms, after comorbidities and triggers have been addressed. Exacerbations on top of that, or oral steroid dependence, is where biologics make a real difference. He notes four of the seven agents Dr. Wechsler described are approved for polyposis.

The agents are boxed into the 5% to 10% with severe asthma, he says, yet the concept of earlier use is very justified. Some data suggest at-risk patients with high biomarker profiles might benefit, but those studies are not published, guidelines will not embrace Step 3 or 4 use, and reimbursement follows guidelines. Clinical remission is real, reached by about 30%, but in severe patients. Whether early treatment prevents progression is unanswered.

Dr. Wechsler calls early treatment akin to preventing a fire rather than putting one out once the damage is done. His caveats are practical. Will payers fund expensive biologics earlier? Will patients accept them to prevent something that may never happen? If they would, he argues, vaccination rates would already be higher, since vaccines effectively prevent frequent exacerbations.

In "Remission in Severe Asthma: Aligning Physician Goals with Patient Goals," the panel will ask what clinicians are actually treating toward.

Videos

Evidence places biologics at GINA Step 5, and that is where reimbursement holds them. Dr. Hanania and Dr. Wechsler examine the case for moving earlier, and what it would require.

Video Series

This episode, "Redefining Treatment Success in IgAN: Remission and Life Beyond Steroids," features the panel reframing the goals of care.

Redefining Treatment Success in IgAN: Remission and Life Beyond Steroids

Seven approved agents across four targets, spanning two decades of approvals. Dr. Wechsler maps the class, then names the 40% of exacerbations it still does not prevent.

Biologics for Severe Asthma: Targets, Timing, and Outcomes

In "Dual vs Single B-Cell Inhibition in IgAN: Duration and Safety Questions," the panel confronts what the trials have not yet answered.

Dual vs Single B-Cell Inhibition in IgAN: Duration and Safety Questions

Sciurba, of University of Pittsburgh, discusses full phase 3 OBERON and TITANIA results, including stronger responses in current smokers.

Tozorakimab Cuts COPD Exacerbations Across Eosinophil Levels: Frank Sciurba, MD

The oral STAT6 degrader achieved deep STAT6 suppression, up to 63% EASI reduction, and gains in asthma and rhinitis scores by week 4.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

KT-621 Achieves Deep STAT6 Degradation, Initial Respiratory, Skin Gains

Pro Vice Provost (International Health) at University College London (UCL), and Vice Dean (International) to the Faculty of Medical Sciences

Hurst discusses data showing durably raised protective AAT levels in patients with alpha-1 antitrypsin deficiency.

Alpha-1 antitrypsin deficiency

BEAM-302 Base Editing Sustains Protective AAT, With John Hurst, MBBS, PhD

Rahul Aggarwal, MD, MBA, is a cardiology fellow at Harvard Medical School.

Rahul Aggarwal, MD, MBA, shares the results of his retrospective cohort study investigating the residual risk of heart failure after patients with prior MI.

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

Structural Heart Disease

Heart Failure Risk Lingers After ST-Elevation Myocardial Infarction

Professor of Respiratory Medicine at Université Paris-Saclay

Olivier Sitbon, MD, PhD, reviews PDGF-targeted therapy in PAH, from imatinib's IMPRES trial to new prodrug and antibody approaches.

PDGF Pathway in PAH: Setbacks and Promise, With Olivier Sitbon, MD, PhD

Jawad Butt, MD, PhD, is a research fellow in the department of cardiology at Copenhagen University Hospital and the University of Glasgow.

Pooled data from 3 trials show H-ISDN cuts all-cause and cardiovascular death in HFrEF, though heterogeneity limits clinical impact.

H-ISDN Meta-Analysis Lowers Mortality in Heart Failure, With Jawad Butt, MD, PhD

Investigator, BC Children's Hospital
Head, Division of Respiratory Medicine, Department of Pediatrics, University of British Columbia
Professor, Department of Pediatrics, Faculty of Medicine, University of British Columbia

Dell discusses an analysis of VOYAGE showing dupilumab more than doubled the odds of favorable asthma outcomes in children, regardless of baseline ICS dose.

Latest News

Lonvo-z BLA Accepted by FDA With Priority Review for HAE

TactiFlex Duo Ablation Catheter Receives FDA Approval for AFib

How Skin Angels Backs Dermatology's Next Innovators, With Ross Levy, MD

Semaglutide Cuts Asthma Attacks by up to 40% in Real-World Study

Positioning Biologics in Asthma: GINA Step 5 and Earlier Treatment