LONDON (dpa-AFX) - GSK plc (GSK) on Tuesday said the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Exdensur for the treatment of asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps.
The approval was based on data from the Phase III SWIFT and ANCHOR trials, which demonstrated sustained efficacy with a twice-yearly dosing regimen.
Exdensur has also received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) and is under regulatory review in other markets, including the United States, Japan and China. Decisions from regulatory authorities are anticipated from December 2025 through the first half of 2026.
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