FDA Approves GSK’s Exdensur for Severe Eosinophilic Asthma

GlaxoSmithKline plc Sponsored ADR

GlaxoSmithKline plc Sponsored ADR

GSK

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GSK plc has announced that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for severe asthma characterized by an eosinophilic phenotype in adults and pediatric patients aged 12 years and older. Exdensur is notable for its twice-yearly dosing, offering sustained protection from exacerbations and potentially reducing the burden on patients and the healthcare system. The therapy has also received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in Europe, with an approval decision expected in early 2026, and regulatory submissions are under review in other countries including China and Japan.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. GSK plc published the original content used to generate this news brief via Business Wire (Ref. ID: 20251216764904) on December 17, 2025, and is solely responsible for the information contained therein.
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