FDA Accepts Depemokimab BLA for Asthma and Chronic Rhinosinusitis with Nasal Polyps

The US Food and Drug Administration (FDA) has accepted a Biologics License Application for depemokimab (GSK) as add-on maintenance therapy for two indications: asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps (CRSwNP).1

The proposed indications are specifically for asthma in adults and adolescents (≥12 years) with type 2 inflammation characterized by an eosinophilic phenotype who remain inadequately controlled on medium- to high-dose inhaled corticosteroids plus another controller, and CRSwNP in adults whose disease remains uncontrolled despite standard-of-care treatment.1

If approved, depemokimab would be the first ultra–long-acting biologic with a 6-month dosing interval for these conditions. The FDA set the Prescription Drug User Fee Act (PDUFA) date for December 16, 2025.1

According to the press release, the phase 3 SWIFT trials (SWIFT-1 and SWIFT-2) showed reductions in asthma exacerbations and hospitalizations among patients with severe asthma and type 2 inflammation treated with depemokimab vs placebo.

Meanwhile, the ANCHOR-1 and ANCHOR-2 trials in CRSwNP demonstrated significant improvements in nasal polyp size and obstruction. The company announced full trials results earlier this week during the 2025 American Academy of Allergy, Asthma and Immunology conference.2

“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,” said Kaivan Khavandi, SVP and Global Head, Respiratory, Immunology & Inflammation R&D for GSK. “Our SWIFT and ANCHOR trials support depemokimab’s potential to suppress interleukin-5 (IL-5), a known driver of type 2 inflammation, to offer patients sustained inhibition of a key driver of their disease with just two doses per year.”1

Depemokimab targets interleukin-5 (IL-5), a key driver of type 2 inflammation, and its extended half-life supports dosing every 26 weeks. In both asthma and CRSwNP, GSK reported that type 2 inflammation is marked by elevated blood eosinophil counts, leading to exacerbations, hospitalizations, and substantial disease burden.1

GSK is also investigating depemokimab in other IL-5–mediated conditions, including eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome.1

Reference

1. GSK. Depemokimab applications accepted for review by the US FDA for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps (CRSwNP). Accessed [Month Day, Year]. https://www.gsk.com/en-gb/media/press-releases/depemokimab-applications-accepted-for-review-by-the-us-fda/
2. Jennings, Sydney. “Depemokimab Shows Significant Improvements in Rhinosinusitis With Nasal Polyps: New Research.” Patient Care Online. Published March 3, 2025. Accessed March 6, 2025. https://www.patientcareonline.com/view/depemokimab-shows-significant-improvements-in-rhinosinusitis-with-nasal-polyps-new-research