Dec 12 (Reuters) – The European Medicines Agency has recommended the approval of GSK’s add-on drug to treat asthma and a chronic inflammatory sinus condition, the company said on Friday. The drug, chemically known as depemokimab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use. The regulator recommended approval for […]
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European health regulator recommends approval for GSK’s twice-yearly asthma drug
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Dec 12 (Reuters) – The European Medicines Agency has recommended the approval of GSK’s add-on drug to treat asthma and a chronic inflammatory sinus condition, the company said on Friday.
The drug, chemically known as depemokimab, received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use.
The regulator recommended approval for the drug as an add-on maintenance treatment for adults and adolescents 12 years and older with severe asthma and type 2 inflammation as well as a condition known as chronic rhinosinusitis with nasal polyps.
The “positive CHMP opinion means that depemokimab could become the first and only ultra-long-acting biologic approved in Europe… In just two doses a year, depemokimab could help redefine care for millions of patients,” said Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology & Inflammation R&D, at GSK.
The panel’s opinion was based on data from two late-stage studies that showed sustained efficacy with a twice-yearly dosing regimen for depemokimab.
The European Commission decision on approval for the drug is expected in the first quarter of 2026.
Depemokimab targets interleukin‑5, a key immune signaling protein, to lower eosinophil‑driven inflammation — a process where excess white blood cells build up in the airways, worsening asthma symptoms. Reducing this inflammation helps ease breathing and cut flare‑ups.
While several other treatment options exist for these conditions, GSK’s drug could be the first that stays longer within a patient’s body, allowing for a twice-a-year dosing option for patients.
Other approved drugs include Sanofi and Regeneron’s blockbuster drug Dupixent, Roche and Novartis’ Xolair, as well as the recently approved Tezspire from Amgen and AstraZeneca as well as GSK’s other respiratory drug Nucala.
The US Food and Drug Administration is also expected to make a decision on approval for depemokimab this month.
(Reporting by Sneha S K in Bengaluru; Editing by Shailesh Kuber)