GSK's (GSK.US) investigational therapy depemokimab has been accepted for filing by the FDA for two indications.

GSK(GSK.US) has announced that the FDA has accepted its Biologics License Application for its investigational therapy, depemokimab, for two indications. These include as an add-on maintenance therapy for adult and adolescent patients aged 12 years and older with asthma who have a 2-type inflammatory phenotype (characterized by blood eosinophil counts) and who are treated with medium to high dose inhaled corticosteroids (ICS) in combination with another asthma controller medication; and as an add-on maintenance therapy for adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) whose disease is not adequately controlled. The PDUFA date for the application is December 16, 2025. If approved, depemokimab would be the first approved ultra-long-acting biologic that requires only once every six months dosing. Notably, the therapy was assessed by industry media Evaluate as a potential blockbuster therapy with a high likelihood of approval in 2025! Depemokimab is an investigational ultra-long-acting biologic targeting interleukin-5 (IL-5). Depemokimab binds to IL-5 with high affinity and is dosed once every six months to treat severe asthma patients. IL-5 is a key cytokine in 2-type inflammation. More than 80% of patients with severe asthma have 2-type inflammation, characterized by elevated eosinophil levels and unpredictable disease exacerbations.