Breaking News, Trials & Filings

FDA Accepts GSK’s Depemokimab for Review

If approved, depemokimab will be the first ultra-long-acting biologic with 6-month dosing.

GSK site in spain.

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...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters