GSK Accelerates Launch After FDA Approval of Nucala for COPD, Eyes £500M Opportunity

GlaxoSmithKline (GSK) has secured another approval for Nucala, this time as an add-on maintenance therapy for adults with inadequately controlled chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. This marks Nucala's fifth approval in the U.S., broadening its utility in treating respiratory conditions. While it wasn't the first biologic to obtain FDA approval for COPD, GSK remains optimistic about the drug's potential impact on this challenging condition.

On the heels of Dupixent's approval for COPD last September and Verona Pharma’s Ohtuvayre in June, Nucala enters a competitive landscape. Unlike Ohtuvayre, which is approved for patients with persistent shortness of breath, Nucala will likely vie with Dupixent, as both cater to patients with high eosinophil levels, a biomarker for type 2 inflammation. This inflammatory lung disease, which encompasses chronic bronchitis and emphysema, is a leading cause of death in the U.S., following heart disease and cancer. Although smoking is a predominant cause, nonsmokers are not immune.

Despite existing inhaled triple therapies, many COPD patients suffer from persistent symptoms and exacerbations. This unmet need underscores the importance of new treatment options. According to Luke Miels, GSK’s chief commercial officer, the company anticipates that Nucala will be a significant asset for physicians treating COPD, particularly given its performance in the phase 3 Matinee study.

Matinee enrolled patients with various COPD diagnoses, including chronic bronchitis and emphysema, or both, which are often challenging to distinguish. In contrast, the trials supporting Dupixent's approval included patients with either chronic bronchitis and emphysema or just bronchitis, excluding those with emphysema alone. Miels emphasized the advantage of Nucala's broad applicability across different COPD types, making it simpler for physicians to prescribe the treatment.

Nucala's ability to reduce hospitalizations is a key selling point, as hospital admissions often signal a severe disease progression. Statistics reveal that one in four hospitalized COPD patients dies within a year, and about half within five years. Thus, avoiding hospitalization is critical, and Nucala aims to help maintain patient stability and home care.

The Matinee study demonstrated Nucala's efficacy, showing a 21% reduction in the annualized rate of moderate or severe COPD exacerbations compared to placebo. For patients exclusively with chronic bronchitis, the drug reduced exacerbation rates by 31%, and it decreased emergency room visits and hospitalizations by 35%. Adverse events were comparable between Nucala and placebo, with COPD exacerbation being the most common issue.

Nucala's approval was strengthened by findings from the Metrex study, which evaluated the drug against placebo in patients with and without an eosinophilic phenotype. GSK, already a prominent player in COPD with its Trelegy Ellipta inhaler, plans to enhance outreach and education for healthcare providers and patients about Nucala's benefits.

Previously, GSK anticipated an FDA decision by May 7, but approval was delayed by two weeks. The company intends to maintain Nucala's existing pricing at approximately $3,800 per injection in the U.S. before discounts. GSK projects Nucala to achieve peak annual sales of 500 million pounds ($669 million) for COPD.

In 2024, Nucala's sales across previous indications grew by 13% to 3.3 billion pounds ($4.4 billion). In the first quarter of 2025, the drug generated 444 million pounds ($594 million), marking a 21% increase over the same period in the prior year.