FDA Approves GSK's Nucala for COPD Treatment

Published 3 hours agoGSK

FDA Approves GSK's Nucala for COPD Treatment

GlaxoSmithKline (GSK) has announced that the U.S. Food and Drug Administration (FDA) granted approval for its drug, Nucala, to be used in treating chronic obstructive pulmonary disease (COPD), also known as 'smoker's lung.' This new approval allows Nucala to be used specifically as an add-on treatment for COPD patients who have an eosinophilic phenotype, characterized by elevated eosinophil levels, which can lead to increased lung inflammation.

The approval follows promising results from the MATINEE Phase 3 trial, which showed that adding Nucala to standard inhaled maintenance therapy significantly reduced the annualized rate of moderate or severe exacerbations in patients compared to a placebo over a period of up to 104 weeks. According to Reuters, such advances are substantial considering that approximately 300 million people worldwide are affected by COPD, with an estimated 40% of these cases involving type 2 inflammation.

In the competitive landscape, other treatments for COPD include Dupixent from Sanofi and Regeneron, and Ohtuvayre from Verona Pharma. Financially, Nucala has been a strong performer for GSK, with sales growing 18% to reach £1.7 billion in 2023, making up nearly 6% of the company's total sales. This approval is expected to further enhance GSK's position in the COPD market.

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