FDA Reviews GSK’s Depemokimab for Asthma and CRSwNP Treatment

The U.S. Food and Drug Administration (FDA) has accepted GlaxoSmithKline’s (NYSE:GSK) biologics license application for depemokimab, an ultra-long-acting monoclonal antibody targeting interleukin-5 (IL-5). The drug is under review for two indications: as an add-on maintenance treatment for asthma in patients aged 12 and older with type 2 inflammation and an eosinophilic phenotype, and as an add-on therapy for adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have not responded to existing treatments.

Depemokimab’s extended half-life allows for just two injections per year, improving patient adherence. The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of December 16 for its decision. Results from the SWIFT and ANCHOR phase III trials demonstrated that depemokimab effectively suppressed IL-5, reducing nasal polyp size and improving asthma control in patients with type 2 inflammation.

Asthma affects over 26 million people in the U.S., with many experiencing severe attacks requiring emergency care. CRSwNP impacts about 2.1% of the population, with 30% of cases leading to worsening symptoms and diminished quality of life. Type 2 inflammation, driven by elevated eosinophil levels, plays a key role in both conditions, contributing to exacerbations and hospitalizations. Up to 85% of CRSwNP patients exhibit type 2 inflammation, making IL-5 inhibition a promising treatment strategy.

Depemokimab is also being studied for other IL-5-mediated conditions like eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome. As research advances, targeting IL-5 may offer new treatment options for respiratory and immune disorders.