FDA approves GSK’s Nucala for COPD treatment

USA – The U.S. FDA has approved GSK’s Nucala (mepolizumab) as an add-on maintenance treatment for adults with chronic obstructive pulmonary disease (COPD) who have an eosinophilic phenotype and poorly controlled symptoms.

The approval came more than two weeks after its expected decision date, but it marks a significant step for GSK in the growing biologics market for respiratory conditions.

Nucala now enters a market currently dominated by Sanofi and Regeneron’s Dupixent (dupilumab), which was the first biologic approved for COPD.

GSK focused its application on patients with a peripheral blood eosinophil count of 150 cells/μl or higher after the FDA previously rejected a broader use of the drug in COPD back in 2018.

Data from GSK’s Phase III MATINEE trial, published in May, showed that Nucala reduced the annual rate of moderate or severe COPD flare-ups by 21% compared to placebo over 104 weeks.

Among patients with chronic bronchitis, the reduction increased to 31%. The study also found a 35% reduction in exacerbations leading to emergency room visits or hospitalizations, though this secondary result was not statistically significant after adjustments.

These findings, while slightly less dramatic than the 30%–34% reduction seen in trials supporting Dupixent’s approval, are still seen as competitive.

GSK executives have expressed confidence in Nucala’s ability to earn a place in COPD treatment, particularly for patients with eosinophilic inflammation.

Kaivan Khavandi, GSK’s global head of respiratory and immunology research, highlighted that repeated flare-ups are a strong predictor of poor long-term outcomes.

The approval of Nucala offers new hope for patients with few options beyond inhalers and steroids.