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- Dec 16, 202590% CONFIDENCEfrom the source
FDA Approves GSK's Exdensur, a Twice-Yearly Severe Asthma Biologic
- GSK announced that the US FDA approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma with an eosinophilic phenotype in adults and children aged 12 years and older[1]
- GSK calls it the first and only ultra-long-acting biologic with twice-yearly dosing approved for this group of severe asthma patients[1]
- In the SWIFT-1 and SWIFT-2 phase III trials it cut the annualised rate of asthma exacerbations by 58% and 48% over 52 weeks versus placebo[1]
- A pre-specified pooled analysis showed a 72% reduction in the annualised rate of exacerbations requiring hospitalisation or emergency visits, and side effects were similar to placebo[1]
- GSK cites an estimated 2 million Americans living with severe asthma, half of whom keep having frequent exacerbations and hospitalisations[1]
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References 480% CONFIDENCEOverall confidence: 80%How well the pin's source and references back up its dates.Weighted average of how firmly 4 references, the source included, support the pin's start and end times; a reference counts half as much for every 180 days older than the newestShow all pins at 75% confidence or better
The first entry is always the pin's source. Overall confidence is a weighted average of how firmly each reference supports the start and end times used above; a reference counts half as much for every 180 days older than the newest.
- [1]90%us.gsk.com/en-us/media/press-releases/exdensur-depemokimab-approved-by-us-fda-for-the-treatment-of-severe-asthmaus.gsk.com· Posted Oct 4, 2026· Starts Dec 16, 2025 ✓· 38% of score
The Business Wire[4] copy of GSK's release carries the 16 December 2025 stamp in its URL (20251216) and The Pharma Letter[3], dated 18 December, says GSK 'yesterday announced' the approval.
- [2]70%GSK's Exdensur gains FDA nod for severe asthma with just two doses a year - Indian Pharma Postindianpharmapost.com· Added Oct 4, 2026· 38% of score
Trade-press report of the approval.[1]
- [3]75%GSK's Exdensur approved by FDA for severe asthma - The Pharma Letterthepharmaletter.com· Published Dec 18, 2025· 12% of score
Trade-press report saying GSK[1] announced the approval 'yesterday'.
- [4]85%Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma - Business Wirebusinesswire.com· Published Dec 16, 2025· 12% of score
Wire copy of GSK's[1] release.
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