FDA Approves GSK’s Ultra-Long-Acting Biologic Exdensur (depemokimab) for Severe Eosinophilic Asthma

Just now, GSK announced that the US FDA has approved Exdensur (depemokimab) as an add-on maintenance treatment for severe asthma characterized by the eosinophilic phenotype, applicable to adult and adolescent patients aged 12 years and older. According to the press release,Exdensur is the first ultra-long-acting biologic approved for patients with severe eosinophilic asthma, requiring dosing only twice a year.It is worth mentioning that,This therapy was assessed by the industry media Evaluate as a potential blockbuster therapy expected to be approved for marketing by 2025.

This approval is based on the results of the SWIFT clinical trial, which showed that, compared with placebo, patients receivingExdensurThe annualized rate of asthma exacerbations was significantly reduced in treated patients.Research analysis shows that, compared with placebo, twice a year on the basis of standard treatmentExdensurSustainably reduce the incidence of acute asthma exacerbations. The results of the SWIFT-1 and SWIFT-2 studies respectively show,Within 52 weeks,ExdensurTreatment significantly reduced the annualized rate of asthma exacerbations (asthma attacks) by 58% (RR=0.42, 95% CI: 0.30-0.59).，p<0.001) and 48%（RR=0.52，95% CI：0.36-0.73，p<0.001）。

ExdensurIt is an ultra-long-acting biologic targeting IL-5. It can bind to IL-5 with high affinity and is administered once every 6 months for the treatment of severe asthma.Patient.IL-5 is one of the key cytokines in type 2 inflammation. More than 80% of severe asthma cases are driven by type 2 inflammation, characterized by elevated eosinophil levels and unpredictable disease exacerbations.

References:

[1] Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma. Retrieved December 16, 2025 from https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-us-fda-for-the-treatment-of-severe-asthma/

Disclaimer: This article is for information exchange purposes only. The views expressed in the article do not represent the position of WuXi AppTec, nor does it imply that WuXi AppTec supports or opposes the views mentioned. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.

Copyright Statement: Individuals are welcome to share this article on their Moments. Unauthorized reproduction by media or institutions in any form to other platforms is prohibited. For authorization to reproduce, please reply with "reprint" on the WeChat Official Account of "WuXi AppTec" to obtain reprint guidelines.