The US Food and Drug Administration (FDA) has accepted for review GSK’s Biologics License Application for depemokimab, a monoclonal antibody targeting IL-5, for two indications: asthma and chronic rhinosinusitis with nasal polyps.

Kaivan Khavandi, SVP and Global Head, Respiratory, Immunology & Inflammation R&D, 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, with its ultra-long-acting properties, offers sustained inhibition of type 2 inflammation with a dosing schedule of just two injections per year.  The FDA’s decision comes after positive results from phase III trials, SWIFT and ANCHOR, which demonstrated depemokimab’s potential to reduce the burden of these conditions.

Depemokimab is currently not approved for use in any country.

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