GSK's Respiratory Drug Nucala Meets Goal in COPD Study

GSK's GSK phase III study evaluating its blockbuster drug Nucala (mepolizumab), an anti-IL5 biologic, for treating chronic obstructive pulmonary disease (COPD), met its primary endpoint.

Data from the MATINEE study showed that in patients treated for up to 2 years, the addition of Nucala to inhaled maintenance therapy led to a statistically significant and clinically meaningful reduction in the annualized rate of moderate/severe exacerbations versus placebo, thereby meeting the study's primary endpoint.

COPD is a respiratory condition that affects more than 300 million people worldwide. Around 40% of COPD patients exhibit type II inflammation, which is associated with an increased risk of exacerbations, which are episodes of worsening respiratory symptoms. IL-5 is a core cytokine in type II inflammation. It promotes the growth and activation of eosinophils, a type of white blood cell involved in the inflammatory response.

GSK stock has risen 17.8% so far this year against a decrease of 2.8% for the industry.

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More on GSK's Nucala Sales

Nucala is already approved in several countries for treating eosinophil-driven diseases like severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis.

Sales of Nucala were up 15% at CER in the first half of 2024 to £856, driven by strong patient demand globally.

Other Players in the Respiratory Diseases Market

Regeneron REGN and Sanofi's SNY blockbuster medicine, Dupixent, an IL-4 and IL-13 inhibitor, was approved for treating COPD in patients with raised blood eosinophils in the EU in July. The European Medicines Agency was the first regulatory authority in the world to approve Sanofi/Regeneron's Dupixent for COPD patients.

In the United States, a supplemental biologics license application (sBLA) seeking approval of Dupixent for COPD is under review with the FDA. The FDA's decision is expected on Sept. 27. Dupixent is currently approved in several countries, including the United States and EU, for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis.

In addition to Dupixent, Nucala faces strong competition from AstraZeneca's Fasenra, also an IL-5 inhibitor like Nucala. Fasenra is approved for treating severe eosinophilic asthma. AstraZeneca is studying Fasenra in late-stage studies for COPD.

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