GSK Files for FDA Approval of Depemokimab in Asthma and Nasal Polyps

GSK has submitted depemokimab for FDA approval in two respiratory indications, marking a significant step towards the potential debut of a new blockbuster treatment. The British pharmaceutical giant is seeking approval for the antibody as an add-on maintenance treatment for asthma in adults and children aged 12 and up, as well as for adults with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

Phase 3 Data Supports Efficacy in CRSwNP

The FDA filings are backed by new phase 3 data from the ANCHOR-1 and ANCHOR-2 trials, which enrolled a total of 528 patients with CRSwNP. Results from a pooled analysis of both trials demonstrated that depemokimab outperformed placebo in improving several secondary endpoints, including:

• Patient-reported severity of runny nose and loss of smell
• Lund-Mackay CT score, a sinus imaging assessment
• SNOT-22, a quality-of-life measure

By week 52, only 26% of patients receiving depemokimab required additional interventions such as corticosteroids, surgery, or disease-modifying medications, compared to 36% in the placebo group.

Long-Acting Treatment with Potential Blockbuster Status

Depemokimab is positioned as an ultra-long-acting treatment, with the potential for twice-yearly dosing in CRSwNP patients. This dosing regimen could provide a significant advantage over competitors like Sanofi and Regeneron's Dupixent, Novartis' Xolair, and GSK's own Nucala, which typically require dosing every two to four weeks.

Dr. Kaivan Khavandi, GSK's global head of respiratory and immunology R&D, emphasized the medical need for alternative treatment options, noting that nearly 40% of CRSwNP patients require repeat surgeries and many depend on long-term systemic corticosteroids.

GSK projects that depemokimab could generate close to $4 billion in annual revenue if approved, underscoring its potential as a major player in the respiratory and immunology market.

Regulatory Timeline and Future Outlook

The FDA has set a PDUFA date of December 16, 2025, for its decision on depemokimab. As the pharmaceutical industry awaits this potential blockbuster premiere, GSK continues to build its case for the antibody's efficacy across multiple respiratory indications.

With these recent developments, depemokimab is poised to potentially reshape the treatment landscape for both asthma and CRSwNP, offering patients a new option with an extended dosing interval and promising efficacy data.