US EditionPublished • loading... • Updated
GSK wins US approval for twice-yearly asthma drug
Exdensur reduces severe asthma exacerbations by up to 58% in clinical trials and offers twice-yearly dosing to improve patient adherence, FDA said.
- On December 17, 2025, the US Food and Drug Administration approved Exdensur for add-on maintenance treatment of severe eosinophilic asthma in patients aged 12 and older.
- GSK's Exdensur is an ultra-long-acting IL-5 biologic designed to reduce injections and improve uptake, as 80% of patients with severe eosinophilic asthma have this phenotype but less than 30% receive biologics, with 65% discontinuing within a year, GSK says.
- Phase III SWIFT-1 and SWIFT-2 trials showed 58% and 48% reductions in annualised exacerbation rates with randomisation 2:1 and dosing at weeks 0 and 26 in patients aged 12 years and older.
- The US Food and Drug Administration limited approval to the severe asthma indication, while the Committee for Medicinal Products for Human Use and UK Medicines and Healthcare products Regulatory Agency cleared two indications, and GSK is discussing the CRSwNP indication with the FDA.
- Entering a crowded biologics market, GSK plc projects $4 billion peak annual sales for Exdensur and sees $3.7 billion potential across indications as Luke Miels takes over next year.
Insights by Ground AI
16 Articles
16 Articles
GSK Gets FDA Approval for New Severe Asthma Drug With a Dosing Advantage
GSK’s Exdensur requires just two injections a year to treat severe asthma. Less frequent injections give this new biologic medicine a dosing edge over one of GSK’s own blockbuster respiratory products as well as severe asthma drugs from companies such as AstraZeneca, Sanofi, and Amgen. The post GSK Gets FDA Approval for New Severe Asthma Drug With a Dosing Advantage appeared first on MedCity News.
MedPage TodayReposted by 
Anti-Aging, Acupuncture and Health News
Anti-Aging, Acupuncture and Health NewsFirst Twice-Yearly Biologic Approved for Severe Eosinophilic Asthma
(MedPage Today) -- The FDA approved depemokimab (Exdensur) as the first ultra-long-acting biologic with twice-yearly dosing approved for patients with severe asthma with an eosinophilic phenotype, GSK announced. The subcutaneous anti-interleukin...
·New York, United States
Read Full Article
Coverage Details
Total News Sources16
Leaning Left1Leaning Right1Center6Last UpdatedBias Distribution75% Center
Bias Distribution
- 75% of the sources are Center
75% Center
13%
C 75%
12%
Factuality
To view factuality data please Upgrade to Premium
