Drug for severe asthma: US regulators have cleared GSK’s new asthma medicine Exdensur as an add-on maintenance option for patients aged 12 and older with severe asthma linked to an eosinophilic phenotype, giving the company a new treatment choice with a twice-yearly dosing schedule.
The approval positions Exdensur (chemical name depemokimab) against a crowded market of asthma biologics, such as Dupixent (Sanofi/Regeneron), Xolair (Roche/Novartis) and Tezspire (Amgen/AstraZeneca), which are typically dosed every two to four weeks. GSK already sells Nucala, another respiratory drug that targets the same IL-5 pathway.
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GSK had also sought US clearance for chronic rhinosinusitis with nasal polyps (CRSwNP), but the FDA declined that indication. The company stated that it remains confident about the benefits and is continuing discussions with the regulator.
The decision lands as GSK is pushing to build its next wave of growth medicines ahead of older products losing exclusivity. Its Commercial Head, Luke Miels, is expected to take over as CEO early next year.