GSK's Nucala achieves success in COPD Phase III trial

GSK's asthma medication Nucala (mepolizumab) has achieved the primary endpoint in a Phase III clinical trial for patients with chronic obstructive pulmonary disease (COPD). The MATINEE study revealed that, when used in conjunction with inhaled maintenance therapy, patients experienced a decreased annual rate of moderate or severe exacerbations compared to those receiving a placebo.

GSK has not provided detailed data but mentioned that the reduction observed was both statistically significant and clinically meaningful over a period of up to two years. The company added that further analysis is in progress, with preliminary safety outcomes aligning with Nucala’s established safety profile.

The study involved 806 patients aged 40 and above who suffer from COPD, a collection of lung conditions that make breathing difficult. This disease impacts over 300 million people globally, predominantly affecting middle-aged and older adults who smoke.

The multi-center, randomized, placebo-controlled, double-blind, parallel-group trial was executed at various sites across the Americas, Europe, Asia, and other regions. Nucala was administered as an additional therapy through a subcutaneous injection every four weeks.

In line with their 2023 earnings report, GSK announced that they expect to submit Nucala for regulatory approval in the European Union and Canada by 2025. However, a specific timeline was not confirmed by a GSK spokesperson.

Nucala is an interleukin-5 (IL-5) antagonist monoclonal antibody and is currently approved for treating asthma. It also has additional approvals for conditions such as chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis (EGPA), and hypereosinophilic syndrome (HES).

Initially approved in 2015, Nucala generated £1.6 billion ($2.1 billion) in revenue for GSK in 2023, marking an 18% increase from the previous year. GlobalData’s Pharma Intelligence Center forecasts that the drug will achieve peak sales of $2.35 billion by 2026.

A major player recently entered the COPD market when the European Medicines Agency (EMA) approved Sanofi's Dupixent (dupilumab) for the disease in July of this year. Dupixent became the first targeted therapy for adults with uncontrolled COPD, specifically those with raised blood eosinophils. Like Nucala, Dupixent is also used to treat asthma, where it holds significant market share. In 2023, the drug generated $11.59 billion in sales, reflecting a 33% rise from the previous year.

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