FDA to review mepolizumab for use in COPD

Image of a doctor and a woman in a hospital bed with oxygen tubes in her nose.

The U.S. Food and Drug Administration (FDA) has accepted data from the MATINEE study as part of the regulatory review process to determine if Nucala (mepolizumab) can be effectively used as an add-on maintenance treatment for patients with COPD with an eosinophilic phenotype.

Nucala manufacturer GSK said in a news release that the MATINEE study evaluated the efficacy and safety of mepolizumab in 804 patients with COPD who have evidence of type 2 inflammation characterized by blood eosinophil count. The trial included a mix of hard-to-treat patients with emphysema only, chronic bronchitis only or a mix of both.

The study met its primary endpoint with the addition of mepolizumab to inhaled maintenance therapy. The drug achieved a statistically significant and clinically meaningful reduction in the annualized rate of moderate to severe exacerbations versus placebo with patients treated for 52 to 104 weeks.

The company said the full results of the MATINEE study will be presented at a future scientific congress. Nucala is currently approved for use in the United States across four conditions, including two respiratory indications as an add-on maintenance treatment for patients at least six years old who have severe asthma with an eosinophilic phenotype. It is also approved as an add-on maintenance treatment for adult patients with chronic rhinosinusitis with nasal polyps and an inadequate response to nasal corticosteroids.

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