GSK's Twice-Yearly Depemokimab Reduces Nasal Polyp Size, Goes Under FDA Review

On Monday, the Food and Drug Administration (FDA) accepted for review GSK plc’s GSK marketing application for depemokimab in two indications.

The company released topline data from the trials in October 2024.

The proposed indications are as add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation characterized by an eosinophilic phenotype on medium- to high-dose inhaled corticosteroids (ICS) plus another asthma controller and, as add-on maintenance treatment in adult patients with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

Also Read: GSK’s Experimental Asthma Drug Reduces Severe Attacks, Phase 3 Trial Data Shows

The Prescription Drug User Fee Act (PDUFA) date is Dec. 16, 2025.

On Saturday, GSK announced full results from the ANCHOR-1 and ANCHOR-2 phase 3 trials of depemokimab versus placebo (both with the standard of care [SOC]) in adults with CRSwNP.

ANCHOR-1 (N=271) and ANCHOR-2 (N=257) met their co-primary endpoints, with twice-yearly administration of depemokimab showing clinically meaningful and statistically significant improvements in nasal polyp size and nasal obstruction versus placebo.

Additionally, a pooled analysis of the two trials showed improvements (reductions) from baseline versus placebo measured by:

• Nasal polyp score (NPS, 0-8) at 52 weeks.
• Mean nasal obstruction scores.

The treatment benefits were observed by the first assessment and sustained to week 52.

In pooled analyses of the secondary endpoints from both studies, nominally significant improvements favoring depemokimab versus placebo were observed.

When considering intervention with surgery or disease-modulating medication alone, the results still trended in depemokimab's favor. Up to 88% (n=239) of depemokimab-treated patients did not have surgery or disease-modulating medication vs. 83% (n=213) in the placebo group.

Price Action: GSK stock is up 2.04% at $38.36 at the last check Monday.

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