GSK (GSK.US) announced that the biologics license application for the investigational therapy depemokimab has been accepted by the FDA for two indications.

GSK (GSK.US) announced that the U.S. FDA has accepted its biologics license application for the investigational therapy depemokimab for two indications. This includes as an add-on maintenance therapy for the treatment of adults and adolescents with type 2 inflammation (as characterized by blood eosinophil counts) asthma aged 12 and older who are receiving moderate to high dose inhaled corticosteroids (ICS) in combination with another asthma control medication; and as an add-on maintenance therapy for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) whose disease is not well controlled. The PDUFA date for this application is December 16, 2025. According to the press release, if approved, depemokimab will be the first approved ultra-long-acting biologic that only needs to be administered every 6 months. It is worth mentioning that this therapy has been evaluated by industry media Evaluate as a potential blockbuster therapy expected to be approved for market in 2025! Depemokimab is an investigational ultra-long-acting biologic targeting interleukin-5 (IL-5). Depemokimab is able to bind to IL-5 with high affinity to treat severe asthma patients with a dosing frequency of every six months. IL-5 is a key cytokine in type 2 inflammation. Over 80% of severe asthma patients have disease driven by type 2 inflammation, characterized by elevated eosinophil levels, and unpredictable exacerbations.