GSK Scores Triple Win as CHMP Backs New Asthma Drug, COPD Indication, and Expanded RSV Vaccine Use

Dec 13, 2025 15:22 CST Updated 15:22

GSK

Pharmaceutical R&D Manufacturer

Cytokinetics

Developer of Muscle Activators and Muscle Inhibitors

Abstract:On December 12, 2025, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) announced a new round of drug recommendations. British pharmaceutical giant GSK emerged as the biggest winner, with key support granted to its long-acting asthma biologic depemokimab, COPD treatment Nucala, and RSV vaccine Arexvy. Additionally, several innovative drugs from China, the United States, and other countries successfully made the list, while the Alzheimer's disease candidate drug blarcamesine was rejected.

Core Breakthrough: New Asthma Drug with Twice-Yearly Injection Poised for Launch in Europe

GSK's depemokimab Becomes the Focus of This CHMP Recommendation. This long-acting IL-5 antagonist is recommended for two types of inflammatory diseases: severe type 2 inflammation asthma in patients aged 12 years and above who are not well controlled with corticosteroids combined with other asthma medications, and chronic rhinosinusitis with nasal polyps (CRSwNP) that is unresponsive to intranasal corticosteroid treatment.

If approved by the European Commission (EC), the drug will be marketed under the brand name Exdensur and require only two injections per year. Kaivan Khavandi, GSK’s Global Head of Respiratory, Immunology, and Inflammation Research and Development, stated that this could become the first ultra-long-acting biologic in Europe for the treatment of both conditions.

Clinical trial data show that in two Phase III studies, depemokimab combined with standard treatment reduced asthma exacerbation rates by 54% compared to placebo, and significantly improved nasal polyp size and nasal congestion symptoms in patients with CRSwNP. GSK expects the drug’s peak annual sales to reach £3 billion (approximately $4 billion), potentially benefiting around 3 million patients with severe asthma in Europe.

GSK Triple Celebration: COPD Indication + RSV Vaccine Expansion

In addition to depemokimab, GSK's monthly injectable biologic Nucala has received CHMP support for expanding its indication to chronic obstructive pulmonary disease (COPD) in patients with inadequate control on triple inhaled therapy. This indication has been approved by the U.S. FDA, with Phase III studies showing a 21% reduction in moderate to severe exacerbation rates.

More notably, GSK's respiratory syncytial virus (RSV) vaccine Arexvy has been recommended for use in all adults, breaking the previous restriction to specific elderly populations. This means the vaccine will cover a broader range of susceptible individuals, further solidifying its position in the RSV vaccine market.

New Drugs from Multiple Countries Shortlisted, Alzheimer's Candidate Drug Rejected

In this CHMP recommendation list, Hansoh Pharma's third-generation EGFR tyrosine kinase inhibitor Aumseqa (Osimertinib) has been recommended for EGFR-mutated non-small cell lung cancer; Cytokinetics' new drug Myqorzo for obstructive hypertrophic cardiomyopathy, as well as Moderna's second-generation COVID-19 vaccine mNEXSPIKE, were also successfully selected.

Merck's pulmonary hypertension drug Winrevair, Eli Lilly's diabetes drug Mounjaro, and others received label expansion support. ImmunityBio's Anktiva received a conditional marketing authorization recommendation for use in combination with BCG to treat high-risk BCG-unresponsive non-muscle-invasive bladder cancer. Clinical trials showed that 71% of patients achieved complete remission, with an average duration of response of 27 months.

However, Anavex Life Sciences' Alzheimer's candidate drug Blarcamesine was rejected by the CHMP. The company stated it will apply for a re-examination, following a negative voting trend for the drug in November.

Currently, drugs like depemokimab are awaiting final approval from the European Commission, with results expected in the first quarter of 2026. Meanwhile, the U.S. FDA is set to make a decision on depemokimab by December 16, marking a critical juncture for GSK's global respiratory disease strategy.

References:https://www.fiercepharma.com/pharma/gsk-long-acting-asthma-med-and-more-secure-chmp-backing

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