(Reuters) -The European Medicines Agency will review GSK’s request to approve its asthma drug Nucala as an additional treatment for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype, the British drugmaker said on Monday. Last September, trial results showed that COPD patients treated with Nucala and an inhaled maintenance therapy for up to 104 […]
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European regulators to review GSK’s asthma drug Nucala to treat COPD
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(Reuters) -The European Medicines Agency will review GSK’s request to approve its asthma drug Nucala as an additional treatment for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype, the British drugmaker said on Monday.
Last September, trial results showed that COPD patients treated with Nucala and an inhaled maintenance therapy for up to 104 weeks had a lower annualised rate of moderate or severe exacerbations than patients given a placebo.
COPD causes restricted airflow and breathing problems and is also known as ‘smoker’s lungs’ because, in Western countries, it primarily affects cigarette smokers.
Nucala is a monoclonal antibody that inhibits interleukin-5, which helps regulate eosinophils, a type of white blood cell that can cause lung inflammation when produced in excess.
GSK said that if approved, Nucala could be the first biologic with monthly dosing for patients with COPD, which affects more than 390 million people globally and over 40 million people in Europe.
Known also as mepolizumab, Nucala was first approved in 2015 for a type of severe asthma in the United States. Its sales grew 12% to about 1.78 billion pounds ($2.30 billion) in 2024, accounting for about 6% of GSK’s overall sales. ($1 = 0.7727 pounds)
(Reporting by Anandita Mehrotra in Bengaluru; Editing by Mrigank Dhaniwala)