With Sunday’s Academy Awards ceremony in the rearview mirror, GSK is looking ahead to a potential blockbuster premiere of its own. The British Big Pharma has filed depemokimab for FDA approval in two respiratory indications on the back of new phase 3 data showing the antibody improved disease symptoms and quality of life in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
The FDA will review depemokimab as an add-on maintenance treatment of asthma in certain adult and pediatric patients aged 12 and up and as an add-on maintenance treatment in adults with inadequately controlled CRSwNP, GSK announced March 3.
The PDUFA date is Dec. 16, 2025.
The new data come from the ANCHOR-1 and ANCHOR-2 trials, which together recruited a total of 528 patients with CRSwNP and gave them either 100 mg depemokimab or placebo.
In a March 1 announcement, GSK revealed the results of a pooled analysis of both trials showing that depemokimab beat placebo at improving several secondary endpoints, including patient-reported severity of runny nose and loss of smell, a sinus imaging assessment called the Lund-Mackay CT score and a quality-of-life measure known as SNOT-22.
By Week 52 in the pooled assessment, 26% of patients on depemokimab had turned to another intervention for their CRSwNP like corticosteroids, surgery or a disease-modulating medication, compared to 36% for patients on placebo, according to the March 1 release.
“Today’s data build on the body of evidence supporting depemokimab as an ultra-long-acting treatment and demonstrate significant reductions in nasal polyps with a twice-yearly dosing regimen,” Kaivan Khavandi, M.D., Ph.D., GSK’s global head of respiratory and immunology R&D, said in the release. “With nearly 40% of patients needing repeat surgeries and many requiring long-term systemic corticosteroids, there is a clear medical need for alternative treatment options.”
GSK presented the data at the 2025 joint congress of the American Academy of Allergy, Asthma and Immunology and the World Allergy Organization. The results were also published in The Lancet.
GSK shared in back in October 2024 that depemokimab reduced nasal polyps in the ANCHOR trials, improving the total endoscopic nasal polyp score at 52 weeks as well as the mean nasal obstruction score from weeks 49 to 52.
CRSwNP is an inflammatory disease that obstructs the sinuses and passages of the nose. The condition can cause pain, stuffiness and loss of smell, and it commonly co-occurs with asthma.
The October ANCHOR results followed an earlier pair of phase 3 wins in the asthma trials SWIFT-1 and SWIFT-2. In the SWIFT trials, GSK’s antibody reduced severe asthma attacks, the primary endpoint, but missed on several secondary endpoints like quality of life, asthma control and how much air a patient can exhale.
At the time, Khavandi chalked those misses up to “significant placebo response, which is obviously an intrinsic challenge with patient-reported outcomes.”
GSK has projected depemokimab to generate close to $4 billion in yearly revenue if approved. The long-acting molecule could require a dose just every six months to treat CRSwNP, compared to the two-to-four-week range seen in competitors like Sanofi and Regeneron’s major blockbuster immunology med Dupixent, Novartis’ Xolair and GSK’s own Nucala.