LONDON (dpa-AFX) - GSK plc (GSK) has announced on Monday that the FDA has accepted its Biologics License Application (BLA) for depemokimab for regulatory review in two indications.
The proposed indications include add-on maintenance treatment for asthma in patients aged 12 and older with type 2 inflammation and an eosinophilic phenotype, as well as add-on maintenance treatment for adults with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). The Prescription Drug User Fee Act (PDUFA) date is set for December 16, 2025.
Kaivan Khavandi, GSK's SVP and Global Head of Respiratory, Immunology & Inflammation R&D, stated that the simultaneous regulatory submissions reflect confidence in depemokimab's ability to reduce the burden of asthma and CRSwNP. He highlighted the SWIFT and ANCHOR trials, which demonstrated depemokimab's potential to suppress interleukin-5 (IL-5), a key driver of type 2 inflammation, with sustained effects from just two doses per year.
Depemokimab is the first ultra-long-acting IL-5-targeting monoclonal antibody to be evaluated in phase III trials and accepted for regulatory review for these conditions. With an extended half-life, high-binding affinity, and potency, the treatment supports a six-month dosing regimen. The SWIFT and ANCHOR trials met their primary endpoints, showing that depemokimab effectively inhibited disease drivers while improving clinical outcomes with minimal injections.
Type 2 inflammation, driven by IL-5, is a key factor in difficult-to-treat asthma and is present in up to 85% of CRSwNP cases. In the U.S., over 26 million people have asthma, leading to 100,000 hospitalizations and nearly 1 million emergency visits annually. Additionally, 2.1% of the U.S. population has chronic rhinosinusitis, with up to 30% affected by nasal polyps, causing symptoms such as nasal obstruction, loss of smell, sleep disturbances, and infections, significantly impacting quality of life.
Currently, depemokimab is not approved for use in any country.
GSK is currently trading at $37.94 or 0.93% higher on the NYSE.
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