6th Feb 2026 08:37
(Alliance News) - GSK PLC on Friday said the European Commission has approved Nucala, or mepolizumab, as add-on therapy for adults with chronic obstructive pulmonary disease.
According to the London-based pharmaceutical firm, clearance was based on results from its phase-three Matinee trial, linking the drug to "clinically meaningful and statistically significant" improvements for lung disease patients.
Those dosed with Nucala had a lower annualised rate of "moderate/severe exacerbations" to their symptoms, when compared with placebo plus standard of care, leading to fewer hospital visits.
Trial participants covered "a wide spectrum of COPD patients with an eosinophilic phenotype, including chronic bronchitis, emphysema only or a combination of both," GSK said.
According to data cited by the company, COPD is currently the third most common cause of death. Nucala is a monoclonal antibody targeting interleukin-5.
The drug has European approval for five indications, including severe asthma, CRSwNP, EGPA, HES and COPD.9.
The regulator's latest decision clears its use as additional maintenance treatment for uncontrolled COPD, which is characterised by raised blood eosinophils, on a combination of an inhaled corticosteroid, a long-acting beta2-agonist, and a long-acting muscarinic antagonist.
Kaivan Khavandi, senior vice president and global head of Respiratory, Immunology & Inflammation R&D at GSK, said: "Nucala could offer relief to the millions of Europeans who need additional options beyond inhaled triple therapy to manage their COPD."
GSK shares were down 0.6% to 2,164.00 pence on Friday morning in London, having gained 46% over the past year.
By Holly Munks, Alliance News reporter
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