EMA Reviews GSK’s Nucala Application for COPD Treatment

GSK plc (LON: GSK) has announced a significant development concerning its asthma medication, Nucala, which is being considered for expanded use. The European Medicines Agency (EMA) has accepted the company's application to broaden Nucala's use to include treatment for chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype.

Up 9.73% year-to-date, GSK's shares have fallen slightly on the day, down 0.96%.

The submission leverages data from the MATINEE trial, a phase 3, double-blind, parallel-group study involving 804 patients. The results indicated that mepolizumab (Nucala's active ingredient) significantly reduced exacerbations compared to a placebo. This could potentially make mepolizumab the first biologic treatment with monthly dosing for COPD, a condition not yet approved for such use across any nation.

COPD presents a serious health burden, affecting more than 40 million individuals across Europe, contributing to increased rates of hospitalization and mortality. On a broader scale, it impacts approximately 390 million people globally, with a societal cost estimated at €164 billion in Europe, based on 2021 data.

Mepolizumab targets interleukin-5 (IL-5), a critical protein in type 2 inflammation. Such inflammation affects up to 40% of COPD patients, highlighting the potential impact of this treatment. While mepolizumab is already approved in Europe for severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome, its application in COPD could fill a critical treatment gap.

The EMA's review of Nucala for COPD marks a pivotal moment for GSK and could potentially lead to an innovative treatment option for millions suffering from this chronic respiratory condition. The decision's outcome could reshape treatment paradigms and offer relief to countless patients across Europe.