EMA accepts GSK's application to expand Nucala use
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GSK said on Monday that the European Medicines Agency has accepted its application to expand the use of ‘Nucala’, or mepolizumab, to include patients with chronic obstructive pulmonary disease (COPD) who have an eosinophilic phenotype.
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The FTSE 100 pharmaceuticals giant said the submission was backed by results from the phase three ‘MATINEE’ trial, which showed a statistically significant and clinically meaningful reduction in the annualised rate of moderate to severe exacerbations when Nucala was added to inhaled maintenance therapy, compared with placebo.
It said the trial enrolled 804 patients and assessed mepolizumab over a period of up to two years.
If approved, mepolizumab would become the first biologic with monthly dosing for patients with COPD.
The drug is already authorised in Europe for several IL-5 mediated conditions, including severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis, but was not yet approved for COPD in any country.
GSK said the MATINEE trial built on findings from the earlier METREX and METREO studies, and was designed to identify patients most likely to benefit from mepolizumab, particularly those with elevated blood eosinophil counts and a history of exacerbations.
Results from the study would be presented at an upcoming scientific congress.
The company noted that COPD affects more than 40 million people in Europe and remains one of the leading causes of hospitalisation and death.
GSK said recurrent exacerbations accelerate disease progression and place further pressure on healthcare systems, highlighting the need for new treatment options.
At 0825 GMT, shares in GSK were down 0.6% at 1,500p.
Reporting by Josh White for Sharecast.com.