Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

Victoria Johnson

chronic obstructive pulmonary disease (COPD) 

has undergone a quiet but profound reassessment. Once viewed as a largely homogeneous condition managed primarily with inhaled bronchodilators and corticosteroids, COPD is now increasingly understood as a biologically diverse disease with multiple inflammatory drivers. This evolving perspective has challenged long-standing assumptions about treatment limitations and opened the door to more individualized approaches.

Recent years have marked a pivotal shift, with biologic therapies—long established in asthma—beginning to demonstrate meaningful benefits in carefully selected COPD populations. Approvals such as dupilumab and mepolizumab have helped redefine what is possible for patients with persistent exacerbations and inflammatory phenotypes, signaling that disease biology, rather than diagnosis alone, may guide future therapy choices.

 These advances have reframed COPD not as a therapeutic dead end, but as a condition ripe for precision medicine.

convened a clinical forum led by Sarah Tomashefski, MSN, AGNP-C, FCCP, Lead Outpatient Pulmonary Advanced Practice Provider, and Director of the Pulmonary APP Fellowship program, Prisma Health, Greenville, South Carolina, focusing on how advanced practice providers (APP) and clinicians are now navigating how to translate emerging data into real-world practice. Questions around patient selection, biomarkers, safety, access, and guideline integration are shaping day-to-day decision-making. The clinical forum captured that moment of transition, reflecting a field actively recalibrating its approach to one of pulmonary medicine’s most challenging diseases.

“[The growing recognition of type 2 inflammation in COPD] opens the door past just the inhalers for a lot of us, where before it's like you get to a point with them and then they're just exacerbating. You're putting them on steroids. And it's like, well, now what do we do? We can see you again, treat you again. But you hit a limit with their treatment. So having the different biologics has definitely opened the door,” Alyssa Minute, DNP, APRN, FNP-C, Upstate Lung & Critical Care Specialists, said during the forum.

The forum explores how improved understanding of COPD heterogeneity has enabled more targeted therapeutic strategies, particularly through biologics aimed at type 2 inflammation. Participants detailed the importance of combining biomarkers such as eosinophil counts with clinical indicators like exacerbation history to identify patients most likely to benefit, while cautioning against indiscriminate use.

In addition to reviewing efficacy and safety considerations, the discussion highlighted practical challenges including reimbursement, workflow integration, and clinician education. Throughout, the conversation reinforced a central theme: the future of COPD management lies not in replacing existing therapies, but in layering precision-based options onto a foundation of optimized standard care.

“I know that there's this big push now for precision medicine. And I feel like just having biomarkers available to help kind of dictate the right tool for the right job is helpful and kind of meeting those new standards for a patient to - obviously, everyone should have individualized care, but it just helps kind of hone in even further [to find the] right tool for a job,” another attendee said.

Dupixent® (dupilumab) Approved in the U.S. as the First-ever Biologic Medicine for Patients with COPD. Regeneron Pharmaceuticals, Inc. September 27, 2024. https://www.globenewswire.com/news-release/2024/09/27/2954552/0/en/Dupixent-dupilumab-Approved-in-the-U-S-as-the-First-ever-Biologic-Medicine-for-Patients-with-COPD.html.

Johnson V. FDA Approves Mepolizumab for Eosinophilic COPD. News release. Article. HCPLive. https://www.hcplive.com/view/personalized-copd-treatment-lessons-biologic-trials-clinical-practice

Articles

Chronic obstructive pulmonary disease is increasingly recognized as a heterogeneous, biologically driven syndrome rather than a uniform airflow-limitation entity, creating momentum for precision-based escalation beyond inhaled therapies. Biologics long used in asthma are now demonstrating benefit in defined COPD subsets, with dupilumab and mepolizumab supporting a type 2 inflammation paradigm in patients with persistent exacerbations. Implementation hinges on rigorous patient selection using biomarkers (eg, blood eosinophils) plus exacerbation history, while addressing safety, reimbursement, workflow integration, and clinician education to layer targeted therapy onto optimized standard care.

Frontline COPD Care in the Biologic Era: Practical Insights From APPs

The past several years have marked a pivotal shift in the treatment of chronic obstructive pulmonary disease, driven by breakthroughs that began reshaping clinical practice in 2024 and continued to evolve through 2025 and into 2026. Long managed primarily with bronchodilators and inhaled steroids, chronic obstructive pulmonary disease (COPD) has entered a new era with the approval of targeted biologic therapies such as dupilumab and mepolizumab.

 These agents, already well established in asthma, have expanded treatment possibilities for a subset of COPD patients defined not just by symptoms, but by underlying biology—particularly type 2 inflammation and eosinophilia.

Against this backdrop, a virtual clinical forum convened by 

and led by David G. Hill, MD, Director, Clinical Research, Waterbury Pulmonary Associates, brought together pulmonologists and advanced practice providers to share their experiences navigating the changing COPD and asthma landscape. The discussion centered on how frontline clinicians are identifying appropriate patients, integrating biomarkers like blood eosinophils into routine care, and balancing emerging evidence with the realities of payer access, patient adherence, and diagnostic uncertainty. 

As biologics move from theory into exam rooms, the forum highlighted both optimism and restraint. Panelists described meaningful improvements in select patients—particularly those with asthma–COPD overlap or steroid-responsive disease—while acknowledging that most COPD patients still lack disease-modifying options. The dialogue underscored a broader shift underway: from treating COPD as a single entity to approaching it as a collection of phenotypes requiring individualized, biologically informed care.

Throughout the forum, clinicians emphasized how recent biologic approvals have changed the way they think about asthma and COPD, particularly for patients who fall into gray areas such as asthma–COPD overlap. Blood eosinophils, bronchodilator responsiveness, and exacerbation patterns have become critical tools for identifying candidates for therapy escalation. Dupilumab emerged as a commonly favored option due to its mechanism, safety profile, and broader labeling, while mepolizumab was viewed as beneficial for select patients with higher eosinophil counts. Despite these advances, panelists repeatedly noted that access barriers, dosing logistics, and payer restrictions often shape real-world decision-making as much as clinical factors.

“I grew up in the era of mild persistent, moderate persistent, severe persistent type [asthma]. We didn't phenotype. We kind of just went with how severe they were and the more severe, the more steroids you gave. I think that has changed. We always knew we didn't want to use too much steroids, but we really didn't have the option. I think now with newer therapies, we have ways to minimize steroid usage, not in everybody, but… much more than we used to,” Paul Strachan, MD, Director of the Stony Brook Pulmonary Hypertension Center, said during the forum.

At the same time, the discussion made clear that biologics address only a fraction of the unmet need in COPD. Most patients continue to live with neutrophilic disease, progressive emphysema, and persistent symptoms that current therapies do not adequately control. Looking ahead, participants called for better biomarkers, earlier disease intervention, and a more personalized approach modeled after advances in oncology. From the frontline perspective, the future of asthma and COPD care lies not just in new drugs, but in redefining how these complex diseases are classified, studied, and treated.

Biologic therapies have begun reshaping COPD management by extending asthma-proven agents, including dupilumab and mepolizumab, to biologically defined COPD subsets characterized by type 2 inflammation and eosinophilia. Clinicians are increasingly using blood eosinophils, bronchodilator responsiveness, and exacerbation history to identify candidates, particularly in asthma–COPD overlap and steroid-responsive phenotypes. Real-world implementation remains constrained by payer policies, dosing logistics, and adherence challenges. Despite momentum, most COPD remains non–type 2, with persistent unmet need for disease-modifying strategies, better biomarkers, and earlier intervention.

From Inhalers to Immunology: Real-World Insights on Biologics in Asthma and COPD

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? 

Top 5 Healthcare Headlines for February 1-7, 2026:

FDA Issues CRL to Dibutepinephrine (Anaphylm) Sublingual Film for Type 1 Allergic Reactions

The FDA issued a Complete Response Letter for sublingual dibutepinephrine after identifying human factors issues that could compromise safe use during anaphylaxis, underscoring the importance of reliable administration in emergency settings.

Positive Topline Data Released on Roflumilast Cream in Infants with Atopic Dermatitis

Phase 2 data indicate roflumilast cream was well tolerated in infants with atopic dermatitis and showed early signs of clinical improvement, supporting potential expansion of topical PDE4 inhibition into this very young population.

FDA Accepts Resubmitted BLA for RelabotulinumtoxinA for Glabellar and Lateral Canthal Lines

The FDA accepted Galderma’s resubmitted BLA for relabotulinumtoxinA following manufacturing process updates, allowing regulatory review to resume for treatment of glabellar and lateral canthal lines.

Upadacitinib Regulatory Applications Submitted for Adults, Adolescents with Vitiligo

AbbVie submitted regulatory applications seeking to expand upadacitinib use to adults and adolescents with non-segmental vitiligo, positioning a systemic JAK inhibitor as a potential option for this underserved condition.

VESPER-3: Positive Results of Long-Term GLP-1 PF’3944 in Overweight and Obesity Without T2D

Positive phase 2b results suggest Pfizer’s long-acting GLP-1 receptor agonist may support sustained weight management with extended dosing intervals in patients without diabetes.

Regulatory and clinical updates spanned acute care, dermatology, aesthetics, and metabolic disease. The FDA issued a CRL for sublingual dibutepinephrine after human factors concerns raised risk of unsafe administration during anaphylaxis. Phase 2 data suggested roflumilast cream was well tolerated in infants with atopic dermatitis with early efficacy signals. The FDA accepted a resubmitted BLA for relabotulinumtoxinA after manufacturing updates. AbbVie filed to expand upadacitinib for non-segmental vitiligo. Phase 2b VESPER-3 supported long-acting GLP-1 PF’3944 for obesity without diabetes.

An audio recap of the top 5 stories in healthcare news from the week of 02/01-02/07.

HCPLive 5 Stories in Under 5: Week of 02/01

Welcome back to our recap of this month's news and updates from the 

In January 2026, the FDA issued a series of approvals and regulatory updates spanning rare hematology, neurology, endocrinology, respiratory, and ophthalmology care. Highlights include the approval of caplacizumab-yhdp (Cablivi) for pediatric aTTP, marking the first approved therapy for children with this life-threatening disorder, and the expansion of Octapharma’s Fibryga kit to a 2-gram presentation for acquired fibrinogen deficiency, improving dosing flexibility in critical bleeding. In endocrinology, the FDA requested removal of suicidal ideation warnings from GLP-1 receptor agonist labeling after extensive safety reviews found no increased risk, while in mental health, ProlivRx became the first at-home neuromodulation therapy for adults with major depressive disorder, demonstrating improved remission rates in the MOOD trial.

Additional highlights in January 2026 include the approval of new discreet packaging for OTC Narcan to increase carry rates and readiness in opioid emergencies, 510(k) clearance of LEADOPTIK’s Last Inch Assessment™ system to enhance lung biopsy accuracy with integrated high-resolution imaging, and Tenpoint Therapeutics’ YUVEZZI, the first fixed-dose dual-agent eye drop for presbyopia, which improved near vision by ≥3 lines in pivotal trials without compromising distance acuity. Here’s a concise overview of the key FDA decisions and updates from January 2026.

Want to hear from the experts? Look for our Related Content links underneath blurbs for insight into how this decision might influence practice moving forward.

1. FDA Approves Caplacizumab-yhdp (Cablivi) as First Treatment for Pediatric aTTP

On January 5, 2026, the FDA approved Sanofi’s caplacizumab-yhdp (Cablivi) for use in pediatric patients aged ≥12 years with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. The decision expands caplacizumab’s 2019 adult indication and makes it the first approved therapy specifically for pediatric aTTP, a rare and life-threatening disorder. Approval was supported by data from a retrospective chart review of 30 patients aged 2–18 years, in which 80% achieved clinical remission, defined by sustained normalization of platelet counts and LDH levels. 

2. FDA Approves 2-Gram Fibryga Kit for Acquired Fibrinogen Deficiency

On January 7, 2026, the FDA approved a new 2-gram presentation of Octapharma’s fibrinogen (human) lyophilized powder for reconstitution (Fibryga) for fibrinogen replacement in patients with acquired fibrinogen deficiency. The expanded presentation builds on Fibryga’s 2024 approval as the first and only virus-inactivated, plasma-derived fibrinogen concentrate approved for this indication in the US and is designed to improve dosing flexibility and speed of administration in critical bleeding settings. 

3. FDA Requests Removal of Suicidal Ideation Risk From GLP-1 RA Labels

On January 13, 2026, the FDA requested the removal of language describing a potential risk of suicidal ideation and behavior from the labeling of select GLP-1 receptor agonists, including liraglutide (Saxenda), semaglutide (Wegovy), and tirzepatide (Zepbound), following a comprehensive safety review. Based on meta-analyses of more than 100,000 patients and large real-world studies, the Agency found no evidence of increased risk for suicidal ideation, self-harm, or other psychiatric adverse events associated with GLP-1 RA use.

4. FDA Approves ProlivRx, First At-Home Neuromodulation Device for MDD

The FDA has approved ProlivRx, the first at-home, physician-directed neuromodulation therapy for adults with major depressive disorder who have not responded to at least one antidepressant, enabling supervised treatment outside of clinic settings. Approval was supported by the MOOD trial, in which ProlivRx significantly improved remission rates versus sham and demonstrated a favorable safety profile, positioning it as a new nonpharmacologic option for difficult-to-treat depression.

5. FDA Approves New Narcan Packaging, Aiming to Boost Carry Rates

The FDA has approved new discreet carrying-case packaging for OTC Narcan (naloxone) nasal spray to improve portability, reduce stigma, and encourage everyday carry. The update addresses persistently low preparedness, as only 10% of the general population reports carrying naloxone despite its OTC availability.

6. FDA Clears LEADOPTIK's LIA System for Higher-Accuracy Lung Biopsy

The FDA has granted 510(k) clearance to LEADOPTIK’s Last Inch Assessment™ system, a first-of-its-kind biopsy-integrated depth imaging technology designed to improve real-time tissue confirmation during lung biopsies. By embedding high-resolution imaging directly into standard biopsy tools, the system aims to close a critical diagnostic gap and improve biopsy accuracy, reported to exceed 95% in preclinical data.

7. FDA Approves First Dual-Agent Eye Drop for Near Vision Loss

The FDA has approved Tenpoint Therapeutics’ YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution 2.75%/0.1%) as the first fixed-dose, dual-agent topical therapy for presbyopia in adults, offering a non-invasive option to improve near vision. Approval was supported by phase 3 BRIO I and II trials demonstrating ≥3-line improvement in binocular uncorrected near visual acuity for up to 8 hours without significant loss of distance vision, with a favorable safety profile including low rates of ocular hyperemia.

The Future of Yuvezzi Eye Drops in Presbyopia, With John Hovanesian

January 2026 FDA actions spanned hematology, bleeding management, endocrinology, neuropsychiatry, harm reduction, pulmonary diagnostics, and ophthalmology. Caplacizumab-yhdp gained the first pediatric (≥12 years) indication for aTTP with high remission in retrospective data. A new 2‑g Fibryga kit enhanced dosing flexibility for acquired fibrinogen deficiency in critical bleeding. After large meta-analyses and real-world evidence, suicidal ideation language was removed from select GLP-1 RA labels. Novel clearances included at-home neuromodulation for MDD, discreet OTC naloxone packaging, biopsy-integrated lung imaging, and a dual-agent presbyopia eye drop.

This FDA News Month in Review provides a round-up of regulatory decisions from January 2026.