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

The United States Food and Drug Administration (US FDA) has approved a supplemental new drug application (sNDA) for Astrazeneca’s albuterol/budesonide, currently approved under the name Airsupra, to expand its indication for adults with mild 

“This label update approved by the FDA ensures that the critical evidence for AIRSUPRA in mild asthma is now included in the prescribing information, allowing physicians to make the most informed decisions about rescue medicine for their patients. This update, along with the recent GINA Report, supports an anti-inflammatory rescue approach for adults of all asthma severities,” Reynold A. Panettieri Jr, MD, Vice Chancellor and Professor of Medicine at Rutgers Institute for Translational Medicine and Science, said in a statement.

The new label includes clinically meaningful evidence from the phase 3b BATURA study in patients with mild asthma. The trial demonstrated that albuterol/budesonide significantly reduced the risk of a severe exacerbation by 46% (hazard ratio [HR], 0.54; 95% CI, 0.40-0.72; 

<.001) compared with albuterol. Investigators also observed a reduction in the annualized severe exacerbation rate (0.15 vs. 0.32; rate ratio, 0.47; 95% CI, 0.34-0.64), and in annualized systemic steroid dose (23.2 vs. 61.9 mg per year). The therapy was well-tolerated, with safety findings consistent with its established safety profile.

The initial US approval of albuterol/budesonide was based on results from the Phase 3 MANDALA and DENALI trials and Phase III DENALI trial (lung function trial in patients with mild to moderate asthma).

In MANDALA, the therapy significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma when used as an as-needed rescue medication in response to symptoms. It also demonstrated a significant reduction in the secondary endpoint of mean annualized total systemic corticosteroid exposure compared to albuterol at the approved dose of 180mcg albuterol/160mcg budesonide. In DENALI, Airsupra significantly improved lung function compared to albuterol and budesonide separately in patients with mild to moderate asthma.

Albuterol/budesonide is a first-in-class, pressurized metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS) in the US. AstraZeneca noted that the Global Initiative for Asthma (GINA) has recommended against SABA-only treatment of asthma in adults since 2019, and furthermore, the 2025 Report from GINA supports an anti-inflammatory rescue approach in adults of all asthma severities.

“Patients living with asthma deserve a treatment that offers more than just relief from their symptoms. With this label update for AIRSUPRA, which includes proven benefits for mild asthma, patients across all asthma severities have a superior choice for their asthma rescue medication,” Liz Bodin, Vice President, US Respiratory & Immunology, AstraZeneca, added.

AIRSUPRA ® (albuterol/budesonide) US prescribing information updated to reflect the statistically significant severe exacerbation risk reduction in patients with mild asthma compared with albuterol. News release. AstraZeneca. September 18, 2025. 

https://www.astrazeneca-us.com/media/press-releases/2025/AIRSUPRA-albuterol-budesonide-US-prescribing-information-updated-to-reflect-the-statistically-significant-severe-exacerbation-risk-reduction-in-patients-with-mild-asthma-compared-with-albuterol.html

LaForce C, Albers F, Danilewicz A, et al. As-Needed Albuterol-Budesonide in Mild Asthma. 

. 2025;393(2):113-124. doi:10.1056/NEJMoa2504544

Airsupra (PT027) approved in the US for asthma. News release. AstraZeneca. January 11, 2023. 

https://www.astrazeneca.com/media-centre/press-releases/2023/airsupra-pt027-approved-in-the-us-for-asthma.html#

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AstraZeneca's Airsupra gains FDA approval for mild asthma, expanding its current label.

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FDA Expands Albuterol/Budesonide Label to Adults With Mild Asthma

Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

Robert Bissonnette, MD
Credit: International Psoriasis Council

Insights from an analysis of nearly a half dozen phase 2 and phase 3 trials of delgocitinib are shedding additional light on the safety and efficacy of the agent in management of chronic hand eczema (CHE).

European Association of Dermatology and Venereology (EADV) 2025 Congress

, the data help to solidify clinicain's understanding of delgocitinib's consistent safety profile for the treatment of moderate to severe CHE in adults, which became the first agent to receive approval for this indication from the US Food and Drug Administration in July 2025.

“The results from the pooled safety analysis are incredibly valuable as they further strengthen our understanding of this treatment option,” said lead investigator Robert Bissonnette, MD, chairman at Innovaderm Research.

 “It is reassuring to see that the safety data pooled from five clinical trials remains consistent with previously established findings.”

Excitement surrounding delgocitinib cream has been building since the debut of phase 3 results from LEO Pharma in October 2023. Since results from the DELTA program were first presented, excitement has reached a fever pitch with the announcement of its approval in July 2025 and, in early September 2025, LEO Pharma announced delgocitinib cream was now available in the US.

The analysis included data from the following trials:

Phase 2b Dose-Finding Trial (NCT03683719)

Results of the analysis, which focused primarily on safety outcomes from the trials, the event rates (R) of AEs with delgocitinib cream (R=302.1) were similar to cream vehicle (R=337.5) and lower than oral alitretinoin (R=830.2) during the initial treatment period. When assessing data from the as-needed treatment period, results indicated the safety profile of delgocitinib cream remained consistent with the initial treatment period, with event rates decreasing in frequency over time.

“We remain deeply committed to further raising awareness of CHE and expanding our extensive scientific research, not only to advance medical dermatology, but, most importantly, to support those living with this debilitating condition,” said Jacob Pontoppidan Thyssen, PhD, chief scientific officer and executive vice president of Science, Search & Innovation at LEO Pharma.

In the same late-breaking session as this data was released, Sonja Molin, MD, presented data from the landmark DELTA TEEN trial. The trial was a phase 3 study of the agent in patients aged 12 to 17 years with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.

The trial had a primary endpoint of Investigator’s Global Assessment for CHE Treatment Success (IGA CHE TS) at week 16, which was defined as an IGA-CHE score of 0/1 (clear/almost clear) with a ≥2 step improvement from baseline. Results from the trial suggested 63.5% of patients achieved the primary endpoint in the delgocitinib cream arm relative to 29.2% in the cream vehicle arm by week 16.

“These results are encouraging and bring us one step closer to advancing the standard of care for this underserved patient group, helping to fulfill their unmet dermatological needs,” said DELTA TEEN investigator Sonja Molin, MD, an academic dermatologist at Charite Universitätsmedizin Berlin and adjunct associate professor of Dermatology at Queen’s University.

LEO Pharma. LEO Pharma Presents Late-Breaking Phase 3 Delgocitinib Cream Data in Adolescents with Moderate to Severe Chronic Hand Eczema (CHE). Leo-pharma.com. Published September 18, 2025. Accessed September 18, 2025. 

https://www.leo-pharma.com/media-center/news/2025-delgocitinib-late-breaker

 Safety of delgocitinib cream in adult patients with Chronic Hand Eczema (CHE): pooled analysis of five phase 2b and phase 3 trials

. Presented at the European Association of Dermatology and Venereology (EADV) 2025 Congress. Paris, France. September 17-20, 2025.

National Eczema Association. LEO Pharma Announces FDA Approval of ANZUPGO® (delgocitinib) Cream in the U.S. National Eczema Association. Published July 25, 2025. Accessed September 18, 2025. 

https://nationaleczema.org/blog/leo-pharma-announces-fda-approval-of-anzupgo-delgocitinib-cream-in-the-u-s/

Delgocitinib has demonstrated a consistent safety profile in managing moderate to severe chronic hand eczema (CHE) in adults, as evidenced by pooled data from multiple phase 2 and 3 trials. The agent, approved by the FDA in July 2025, shows similar adverse event rates to cream vehicle and lower rates than oral alitretinoin. The DELTA TEEN trial further supports its efficacy in adolescents, with a significant percentage achieving treatment success. These findings underscore delgocitinib's potential to advance care for patients with CHE.

New findings confirm delgocitinib cream's safety and efficacy for chronic hand eczema, marking a significant advancement in treatment options.

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Pooled Phase 2/3 Data on Delgocitinib Illustrate Consistent Safety Profile in CHE

Anusha Pasumarthi, MD, is a Dermatopharmacology Fellow at the Icahn School of Medicine.

New findings suggest ritlecitinib treatment led to favorable safety data and rapid improvements in 

 clinical scores, supporting the use of JAK3/TEC inhibition for this set of conditions.

These findings were presented in a late-breaking data session at the 

European Academy of Dermatology and Venereology (EADV) 2025 Congress

 in Paris. They were presented by Anusha Pasumarthi, MD, MSc, a dermatopharmacology fellow at the Icahn School of Medicine, who spoke with 

Discussing New Ritlecitinib Findings in Cicatricial Alopecia, With Anusha Pasumarthi, MD

“We have the three disease groups, which included FFA, or frontal fibrosing alopecia, as well as lichen planopylares and CCCA,” Pasumarthi explained. “Of those three groups, we basically realized that through our data, all three of them had statistically significant improvements in the grading scores that we use to decide how severe the disease is, as well as clinical improvements in terms of photographic evidence that I'll be presenting as well today. It's very promising to see that. Not only did we see the improvements of the scores clinically and statistically, we also noted a correlation between biomarkers that were being downregulated as we saw the scores improving.”

Pasumarthi highlighted the value of these findings among patients living with these 3 types of cicatricial alopecia.

“I think this clinical trial is providing us a window, if you will, into an unexplored territory that I'm sure that many patients would benefit from, as well as clinicians,” Pasumarthi said. “Because, like I said, it is truly a debilitating disease. Unfortunately, we have no FDA-approved treatments to offer them right now, so [we have] hope that once we see the down regulation of the inflammation that we saw today…when you treat these patients long enough, and you keep the inflammation at bay, we truly [may] start adjusting the fibrosis that's happening in the scalps as well. And, hopefully at some point, reverse it.”

To find out more about Pasumarthi’s team’s conclusions related to ritlecitinib, view our summary of these recent findings.

Pasumarthi had no relevant financial relationships or in-kind support to disclose.

Del Duca E, Lau M, Yassky EG, et al. JAK3/TEC Inhibition is Safe and Effective in Cicatricial Alopecias: Evidence from a Prospective Trial. Presented at the 2025 European Academy of Dermatology and Venereology (EADV) Congress, Sept 17-20, 2025.

Smith T. JAK3/TEC Inhibition Through Ritlecitinib Effective, Safe for Cicatricial Alopecias. HCPLive. September 18, 2025. 

https://www.hcplive.com/view/jak3-tec-inhibition-through-ritlecitinib-effective-safe-cicatricial-alopecias

Videos

Ritlecitinib treatment has shown promising results in improving clinical scores and safety profiles for cicatricial alopecia, including frontal fibrosing alopecia, lichen planopylares, and CCCA. The findings, presented at the EADV 2025 Congress, indicate statistically significant improvements in disease severity and clinical outcomes, supported by photographic evidence and biomarker downregulation. This research offers hope for patients with these debilitating conditions, as there are currently no FDA-approved treatments. Continued treatment may potentially address and reverse scalp fibrosis, providing a new therapeutic avenue for clinicians and patients.

In this interview at EADV, Pasumarthi highlights her team’s late-breaking data on ritlecitinib’s use among patients with cicatricial alopecias.

Alopecia

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.

Tamara Hannon, MD | Image Credit: Riley Children's Health

Tirzepatide (Mounjaro) met the primary and all key secondary endpoints in the phase 3 SURPASS-PEDS trial, achieving superior improvements in both A1C and body mass index (BMI) versus placebo in adolescents with 

Presented by parent company Eli Lilly and Company at the European Association for the Study of Diabetes (EASD) Annual Meeting 2025, SURPASS-PEDS is the first phase 3 trial evaluating the safety and efficacy of tirzepatide in children and adolescents, ages 10-18, with T2D inadequately controlled with metformin, basal insulin, or both. Tirzepatide had achieved its endpoints by week 30.

Eli Lilly’s Mounjaro was first approved by the US Food and Drug Administration (FDA) in May 2022 as an injection for use as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D). At the time, it was the first and only FDA-approved GIP/GLP-1 receptor agonist.

“Youth living with T2D often face a more aggressive disease course, and in many instances, first-line treatments like metformin and basal insulin fail to control their A1C adequately,” Tamara Hannon, MD, director of the Clinical Diabetes Program at the Indiana University School of Medicine and lead investigator in the trial, said in a statement. “The SURPASS-PEDS results show that [tirzepatide] delivered significant and clinically meaningful improvements in blood sugar, BMI, and fasting serum glucose in pediatric patients.”

SURPASS-PEDS is a regulator-required, multicenter, randomized, double-blind, placebo-controlled trial with an open-label extension. Investigators randomly assigned 99 participants to either tirzepatide 5mg, 10mg, or placebo once weekly. The primary endpoint was to prove tirzepatide’s superiority to placebo in mean A1C change from baseline after 30 weeks.

Included patients weighed ≥50 kg, had an A1C of >6.5% to ≤11% at screening, and BMI >85

 percentile of the general age- and gender-matched population for the corresponding country or region. Average baseline A1C among the participants was 8.04%, average BMI was 35.4 kg/m2, and average baseline weight was 96.6 kg. Average baseline BMI standard deviation score was 3.11 and average diabetes duration was 2.4 years.

Ultimately, pooled tirzepatide doses lowered A1C by an average of 2.2% from baseline. A key secondary endpoint highlighted 86.1% of participants assigned to tirzepatide 10mg achieved a target A1C of ≤6.5%. Additionally, tirzepatide saw clinically meaningful improvements in BMI, with the 10mg dose reducing it by 11.2% on average at 30 weeks. Improvements continued through the long-term extension of 52 weeks.

Investigators also noted the consistency of the safety profile with the established incretin class, including data from the previous SURPASS trials. The most common adverse events for patients receiving tirzepatide 5mg, 10mg, and pooled doses respectively were diarrhea (25%, 24%, and 25% vs 6% with placebo), nausea (22%, 18%, and 20% vs 9% placebo), vomiting (16%, 12%, and 14% vs 3% with placebo), and abdominal pain (16%, 3%, and 9% vs 3% with placebo). No episodes of severe hypoglycemia were observed.

“The SURPASS-PEDS results show [tirzepatide] delivered statistically significant improvements in A1C, BMI, and other critical cardiometabolic risk factors, while maintaining a safety profile generally consistent with adult studies,” Kenneth Custer, PhD, executive vice president and president of Lilly Cardiometabolic Health, said in a statement. “By undertaking this research, we can better support children and adolescents living with this condition.”

In the same press release, Lilly announced submission of the SURPASS-PEDS results to global regulatory agencies, seeking an expanded indication.

Lilly’s Mounjaro (tirzepatide), a GIP/GLP-1 dual receptor agonist, reduced A1C by an average of 2.2% in a Phase 3 trial of children and adolescents with type 2 diabetes. Eli Lilly and Company. September 17, 2025. Accessed September 18, 2025. 

https://investor.lilly.com/news-releases/news-release-details/lillys-mounjaro-tirzepatide-gipglp-1-dual-receptor-agonist

FDA approves Lilly’s Mounjaro (tirzepatide) injection, the first and only GIP and GLP-1 receptor agonist for the treatment of adults with type 2 diabetes. Eli Lilly and Company. May 13, 2022. Accessed September 18, 2025. 

https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-mounjarotm-tirzepatide-injection-first-and#:~:text=News%20Release-,FDA%20approves%20Lilly's%20Mounjaro%E2%84%A2%20(tirzepatide)%20injection%2C%20the%20first,with%20type%201%20diabetes%20mellitus

Tirzepatide (Mounjaro) demonstrated significant efficacy in the phase 3 SURPASS-PEDS trial, achieving superior A1C and BMI improvements in adolescents with type 2 diabetes compared to placebo. Conducted by Eli Lilly, this trial is the first to evaluate tirzepatide in a pediatric population inadequately controlled with metformin or basal insulin. The trial met its primary endpoint by week 30, with pooled doses reducing A1C by 2.2% and the 10mg dose reducing BMI by 11.2%. The safety profile was consistent with previous studies, and no severe hypoglycemia was observed.

Tirzepatide saw improvements in A1C and body mass index, which were maintained over the 30-week trial and into the 52-week extension study.

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SURPASS-PEDS: Tirzepatide Achieves Superiority to Placebo in Adolescent T2D

Sonja Molin, MD 
Credit: Charite Universitätsmedizin Berlin

 suggests use of delgocitinib cream (Anzupgo) was effective and safe in managing 

Known as the DELTA TEEN study, results of the phase 3 trial demonstrated superior efficacy with delgocitinib cream compared to cream vehicle among a population aged 12 to 17 years with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.

“The findings from the phase 3 DELTA TEEN trial may offer hope for young people whose CHE can impact their wellbeing and leisure activities,” said study investigator Sonja Molin, MD, an academic dermatologist at Charite Universitätsmedizin Berlin and adjunct associate professor of Dermatology at Queen’s University.

“These results are encouraging and bring us one step closer to advancing the standard of care for this underserved patient group, helping to fulfill their unmet dermatological needs.”

Delgocitinib cream capture the attention of dermatologists and the medical community in July 2025 when it became the first agent to receive approval from the US Food and Drug Administration for CHE—making it the first agent to ever receive such an indication. The approval of the topical pan-Janus kinase (JAK) inhibitor was based on data from the DELTA 1 and DELTA 2 trials.

At EADV, Molin presented data from DELTA TEEN, which was a 16-week, phase 3, randomized, double-blind, vehicle-controlled, parallel group trial launched to evaluate the efficacy and safety of twice-daily delgocitinib cream compared with cream vehicle in adolescents 12 to 17 years of age with moderate to severe CHE.

The trial, which included 98 individuals, and had a primary endpoint of Investigator’s Global Assessment for CHE Treatment Success (IGA CHE TS) at week 16, which was defined as an IGA-CHE score of 0/1 (clear/almost clear) with a 2 step or greater improvement from baseline.

Results from the trial suggested 63.5% of patients achieved the primary endpoint in the delgocitinib cream arm relative to 29.2% in the cream vehicle arm. Further analysis indicated use was associated with a greater proportion of patients achieving other meaningful endpoints relative to vehicle cream, including a ≥90% improvement in the Hand Eczema Severity Index (HECSI-90) score from baseline to week 16 (71.6% vs. 37.5%) and a 4-point or greater reduction in Hand Eczema Symptom Diary (HESD) itch (64.8% vs. 36.8%), pain (63.3% vs. 33.3%), and total (55.6% vs. 31.3%) scores from baseline to week 16.

Safety data from DELTA TEEN indicated 0 serious adverse events were reported in the trial, with reported events with delgocitinib cream considered mild or moderate in severity. Additionally, investigators pointed out events probably or possibly related to the trial drug and events leading to withdrawal from the trial or permanent discontinuation were reported, with numerically lower rates for delgocitinib cream than vehcile cream.

“Nearly half of CHE patients feel they are a burden to their families, and around 63% avoid holding hands with their partners, highlighting the profound everyday impact this disease can have on patients’ lives. These figures are more than just statistics; they reflect the real and often unseen challenges faced by those living with CHE,” said Jacob Pontoppidan Thyssen, PhD, chief scientific officer and executive vice president of Science, Search & Innovation at LEO Pharma.

 DELTA TEEN Phase 3 trial: Efficacy and Safety of Delgocitinib Cream in Adolescents with Moderate to Severe Chronic Hand Eczema

Delgocitinib cream has shown efficacy and safety in managing chronic hand eczema (CHE) in adolescents, as demonstrated by the DELTA TEEN phase 3 trial. The trial revealed that delgocitinib cream significantly outperformed the cream vehicle in achieving treatment success and improving symptoms such as itch and pain. The cream was well-tolerated, with no serious adverse events reported. This development marks a significant advancement in the treatment of CHE, offering hope for adolescents whose condition impacts their quality of life and daily activities.

New research highlights delgocitinib cream's effectiveness for treating chronic hand eczema in adolescents. 

DELTA TEEN: Delgocitinib Proves Benefit in Teens with Chronic Hand Eczema

Abigail Brooks is an assistant editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

The 2025 guideline updates previous recommendations made in the 2021 glomerular disease guideline based on recent therapeutic advances in IgAN.


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Discover how roflumilast foam transforms treatment for seborrheic dermatitis, showing effectiveness across diverse skin tones.

STRATUM Trial: Roflumilast Foam Works Across Skin Types, With Raj Chovatiya, MD, PhD

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

This analysis highlights the safety and efficacy of JAK3/TEC inhibition in cicatricial alopecias, presented at EADV.

JAK3/TEC Inhibition Through Ritlecitinib Effective, Safe for Cicatricial Alopecias

These late-breaking data at EADV highlight predictive factors for early super response to treatment with bimekizumab for psoriasis.

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Bimekizumab Effective in Bio-Naïve, Bio-Experienced Patients with Psoriasis

New phase 2b data reveals temtokibart significantly improves atopic dermatitis symptoms in adult patients.

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This interview segment highlights Song’s risankizumab data covered during the 2025 EADV Congress in Paris.

Risankizumab and Treatment Sequencing in Scalp and Genital Psoriasis, With Eingun James Song, MD

These HS-OBTAIN phase 2a trial data highlight the impacts of treatment with brivekimig on patients naïve to biologics with moderate-to-severe HS.

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HS-OBTAIN: Brivekimig Achieves Positive Results in Hidradenitis Suppurativa

Harrington and Desai weigh in with their thoughts on the bumetanide approval and how we can continue to battle edema in heart failure.

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Chief of Pediatric Rheumatology at Hackensack University Medical Center, and Professor of Pediatrics at the Hackensack Meridian School of Medicine.

Kimura highlighted some of her ongoing research tackling high priority questions in JIA.

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A study suggests associations between opioids during pregnancy and neurodevelopmental disorders are mainly due to confounding factors, not causal effects.


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Latest News

FDA Expands Albuterol/Budesonide Label to Adults With Mild Asthma

Pooled Phase 2/3 Data on Delgocitinib Illustrate Consistent Safety Profile in CHE

Discussing New Ritlecitinib Findings in Cicatricial Alopecia, With Anusha Pasumarthi, MD

SURPASS-PEDS: Tirzepatide Achieves Superiority to Placebo in Adolescent T2D

DELTA TEEN: Delgocitinib Proves Benefit in Teens with Chronic Hand Eczema