3rd Mar 2025 09:56
(Alliance News) - GSK PLC on Monday said the US Food & Drug Administration has accepted for review the biologics license application for depemokimab in two indications - for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps.
If approved, the London-based pharmaceuticals company said depemokimab will be the first ultra-long-acting biologic with 6-month dosing.
Submissions were based on data from positive Swift and Anchor phase trials, GSK added. The Swift-1 and -2 trials showed depemokimab reduced exacerbation and hospitalisation rates as an add-on therapy for patients with asthma with type 2 inflammation versus placebo.
The Anchor-1 and -2 studies showed early and sustained reductions in nasal polyp size and nasal obstruction versus placebo.
Kaivan Khavandi, global head of Respiratory, Immunology & Inflammation R&D at GSK, said: "Simultaneous regulatory submissions for two indications highlight our confidence in depemokimab to help reduce the burden of both asthma and CRSwNP for patients and health systems."
Depemokimab is currently not approved for use in any country, GSK noted.
Shares in GSK were 0.7% higher at 1,477.00 pence each in London on Monday morning.
By Jeremy Cutler, Alliance News reporter
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