GSK Submits BLA for Depemokimab, a Twice-Yearly Ultra-Long-Acting IL-5 Inhibitor, for Severe Eosinophilic Asthma and CRSwNP
GSK
Pharmaceutical R&D Manufacturer
On March 3 local time, GSK announced that the US FDA had accepted Depemokimab.（Dermochimab）Biologics License Application for Two Indications.
The proposed indication is:For patients with Type 2 inflammation characterized by eosinophilic phenotypeAsthmaAdults and pediatric patients 12 years of age and older using medium to high doses of inhaled corticosteroids (ICS) Add another asthma control medication for adjunctive maintenance therapy, as well as for poorly controlled cases.Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)Adult patients undergoing adjuvant maintenance therapy.PDUFA Date: December 16, 2025。
Screenshot source: Corporate official website
Depemokimab is a monoclonal antibody targeting IL-5.IL-5 is a key cytokine in type 2 inflammation(Protein)。Type 2 inflammation, typically identified through blood eosinophil counts, is a potential driving factor in many diseases.This type of inflammation is present in most patients with difficult-to-treat asthma and may lead to worsening of the condition and hospitalization.。Up to 85% of patients with CRSwNP also have Type 2 inflammation, which is associated with more severe disease and symptoms.
The press release pointed out,Depemokimab YesThe FirstEvaluated in Phase III trials and under regulatory review for the treatment of these diseasesUltra-long-acting biologics. If approved, the drug will becomeThe First Ultra-Long-Acting Biologic with a 6-Month Dosing Cycle。
SWIFT-1 and SWIFT-2 are 52-week randomized, double-blind, placebo-controlled, parallel-group, multicenter Phase III clinical trials. The trials evaluated the efficacy and safety of Depemokimab as an add-on therapy for patients with eosinophilic asthma.
ANCHOR-1 and ANCHOR-2 are duplicate Phase III clinical trials with identical primary and secondary endpoints, designed to evaluate the safety and efficacy of Depemokimab as an adjunctive treatment for adult patients with CRSwNP.
Based on the results of the SWIFT and ANCHOR trials, Depemokimab's extended half-life, high binding affinity, and potency support a six-month dosing interval.(26 weeks)The dosing regimen. For asthma patients with type 2 inflammation and CRSwNP patients, these trials met their primary endpoints, indicating that Depemokimab can continuously suppress key drivers of their diseases and throughOnly twice a yearThe dosing regimen helps achieve critical clinical outcomes.
Apart from the two indications already reported for marketing,Depemokimab is also being developed for other IL-5 mediated diseases, including for the treatment ofEosinophilic Granulomatosis with Polyangiitis (Experiment Code: EGPA)OCEAN and for treatmentEosinophilia(Trial Code: HES)DESTINY
Insight database shows that globally, there are 12 IL5/IL5R monoclonal antibody pipelines under research, includingBenralizumab（Kyowa Kirin）、Retuximab(UCB/Schering-Plough)、Mepolizumab（GSK）Approved for marketing in China, GSKDepemokimabIs currently in the application phase for market launch. Besides, the one with relatively faster progress isHengrui SHR-1703 and3SBioSSGJ-610, both in clinical Phase III, with the first indication being eosinophilic asthma.
Screenshot source: Corporate official website
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