FDA Accepts GSK’s Submission for Use of Mepolizumab in COPD

GSK announced today that the US FDA has accepted for review its submission to extend the use of mepolizumab (Nucala) as an add-on maintenance treatment for people with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.

The Prescription Drug User Fee Act date is set for May 7, 2025, according to a December 9, 2024, press release from GSK. If approved, mepolizumab would be the first biologic approved with monthly dosing for adults with COPD, the company said.

The submission was supported by data from the phase 3 MATINEE clinical trial, which showed a significant and clinically meaningful decrease in the annualized rate of moderate-to-severe COPD exacerbations when mepolizumab was added to inhaled maintenance therapies compared to placebo over a treatment period of 52-104 weeks. The trial included 804 people with COPD who had broad clinical presentations of chronic bronchitis and/or emphysema and had evidence of type 2 inflammation characterized by blood eosinophil count.

COPD affects over 14 million people in the US and accounts for approximately 500 000 hospitalizations and 1.3 million emergency department visits annually, according to GSK. Type 2 inflammation, driven by interleukin 5 (IL-5), underlies disease pathophysiology in up to 40% of patients with COPD. Blood eosinophil count serves as a biomarker to identify patients who may benefit from targeted IL-5 inhibition.

Mepolizumab, an anti–IL-5 monoclonal antibody, was first approved by the FDA in 2015 as an add-on maintenance treatment for patients aged ≥6 years with severe asthma with an eosinophilic phenotype. It is also approved for other eosinophilic conditions, including eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome. If approved for COPD, mepolizumab would become the first biologic therapy with monthly dosing for this patient population.

The MATINEE study included patients with diverse clinical presentations of COPD, including emphysema, chronic bronchitis, or mixed phenotypes, highlighting the broad applicability of mepolizumab. GSK is set to present detailed findings from the MATINEE study at an upcoming scientific congress, reinforcing the data's impact on regulatory submissions globally.

Reference: US FDA accepts GSK’s submission for the use of Nucala (mepolizumab) in COPD. News release. GSK. December 9, 2024. Accessed December 9, 2024. https://www.gsk.com/en-gb/media/press-releases/us-fda-accepts-gsk-s-submission-for-the-use-of-nucala-mepolizumab-in-copd/