FDA Approves GSK's Nucala for Expanded Use in COPD

GSK plc GSK announced that the FDA has approved its blockbuster respiratory drug, Nucala (mepolizumab), for a fifth indication. The drug is now cleared to treat certain patients with chronic obstructive pulmonary disease (COPD).

With this latest nod, Nucala is approved as an add-on maintenance treatment for adult patients with inadequately controlled COPD and an eosinophilic phenotype. The decision came two weeks later than the original deadline of May 7.

Nucala is already approved for severe asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome in certain countries, including the United States and Europe.

More on GSK’s Nucala Approval in COPD

The label expansion was supported by data from the late-stage MATINEE study, which achieved its primary endpoint. Data from this study showed that adding Nucala to inhaled maintenance therapy significantly and meaningfully reduced the annualized rate of moderate to severe exacerbations compared to placebo in patients treated for 52 to 104 weeks. Regulatory filings based on this study are currently under review in Europe and China, seeking approval for the drug in the COPD indication.

Exacerbations are acute episodes of worsening COPD symptoms that can lead to hospitalization and irreversible lung damage. Preventing exacerbations is a key goal for managing COPD.

COPD is a life-threatening respiratory disease that damages the lungs and causes progressive lung function decline. The disease affects more than 390 million people globally and is the third leading cause of death worldwide.

The latest approval further supports GSK’s long-term strategy. The company aims to generate more than £40 billion in annual sales by 2031, focusing on HIV, immunology/respiratory and oncology therapeutic areas.

This year, GSK expects to launch five new products or line extensions. The FDA has already approved three products — Blujepa (for uncomplicated urinary tract infections), Penmenvy (the 5-in-1 meningococcal vaccine) and Nucala (in COPD) — during the first half of 2025. Regulatory decisions on the remaining two — Blenrep (relaunch in multiple myeloma) and depemokimab (for severe asthma and chronic rhinosinusitis with nasal polyps) — are expected in the second half of the year.

GSK Stock’s Performance

Year to date, shares of GSK have gained 15% against the industry’s 6% decline.

Recent Developments in the COPD Space

The FDA’s decision makes Nucala the second biologic treatment approved for the disease and the third new COPD drug approved in the country in the past year.

Sanofi SNY and partner Regeneron’s REGN blockbuster immunology drug Dupixent was the first biologic treatment for COPD. The Sanofi/Regeneron drug was approved by the FDA for an indication similar to Nucala last year in September. Once GSK’s drug is commercially launched in the COPD indication, it will directly compete with Sanofi/Regeneron’s Dupixent for market share.

Notably, the FDA approved Verona Pharma’s VRNA Ohtuvayre for the maintenance treatment of COPD in adult patients last year. Following this approval, the Verona Pharma medication became the first inhaled product with a novel mechanism of action available as COPD maintenance treatment in more than 20 years. Unlike the currently available COPD therapies, Verona Pharma’s Ohtuvayre combines two properties in one medicine — it opens the airways of patients, making it easier for them to breathe while reducing inflammation in the lungs without using steroids.

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