23rd May 2025 08:27
(Alliance News) - GSK PLC on Thursday said the US Food & Drug Administration has approved its asthma drug Nucala as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease, or COPD, who have an eosinophilic phenotype.
The London-based pharmaceutical company said the approval makes Nucala the first biologic authorised in the US for a broad COPD population with a blood eosinophil count starting at 150 cells/μL.
The decision was based on positive results from the phase III Matinee and Metrex trials, which showed that Nucala significantly reduced moderate and severe exacerbations in patients already on inhaled triple therapy.
GSK noted that around 70% of COPD patients in the US who remain symptomatic on triple therapy have a blood eosinophil count of 150 cells/μL or more, a group that could now benefit from Nucala to reduce the risk of exacerbations and hospitalisation.
"Today there is hope for improved care for COPD patients with an eosinophilic phenotype," said Kaivan Khavandi, global head of respiratory R&D at GSK.
Exacerbations of COPD are a key predictor of disease progression, GSK said, and managing them is a major burden on healthcare systems. In the US alone, exacerbation-related hospital visits cost about USD7 billion annually.
Mepolizumab is not currently approved for COPD treatment outside the US, though regulatory submissions are under review in China and Europe.
GSK shares opened 1.0% higher at 1,442.50 pence in London on Friday.
By Eva Castanedo, Alliance News reporter
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