GSK Gets EU Approval for Expanded Use of Nucala in COPD

GSK plc GSK announced that the European Commission has approved its blockbuster respiratory drug, Nucala (mepolizumab), for treating certain patients with chronic obstructive pulmonary disease (COPD), marking a new indication for the drug.

Nucala is now approved as an add-on maintenance treatment for uncontrolled COPD in adults who have a raised blood eosinophil count on a combination of an inhaled corticosteroid, a long-acting beta2-agonist and a long-acting muscarinic antagonist in the European Union.

The EU approval was expected as the Committee for Medicinal Products for Human Use of the European Medicines Agency rendered a positive opinion recommending the approval of Nucala as an add-on maintenance treatment for COPD in December 2025.

Nucala is the first and only monthly biologic in the EU to be studied in a broad group of COPD patients with an eosinophilic phenotype.

The FDA approved Nucala for the treatment of COPD in May last year, marking the fifth approved indication for the drug in the United States.

GSK’s Price Performance

Over the past six months, GSK’s shares have surged 57.5% compared with the industry’s rally of 43.5%.

More on the EU Nod for GSK’s Nucala in COPD

The approval for Nucala in the EU was based on positive data from the phase III MATINEE study. Data from the same showed that treatment with Nucala led to a clinically meaningful and statistically significant reduction in the annualized rate of moderate/severe exacerbations versus placebo plus standard of care in a broad group of COPD patients.

Data from the MATINEE study also demonstrated treatment with Nucala led to a reduction in exacerbations, leading to emergency department visits and/or hospitalizations versus placebo.

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 affects more than 390 million people globally, including about 40 million in Europe. The disease ranks as one of the leading causes of hospitalization in many countries globally.

Nucala is a monoclonal antibody with a novel mechanism of action that targets IL-5, a key messenger protein (cytokine) in type 2 inflammation.

Besides COPD, Nucala is also approved in Europe and the United States for four other IL-5-mediated conditions. These are severe asthma, eosinophilic granulomatosis with polyangiitis, chronic rhinosinusitis with nasal polyps and hyper-eosinophilic syndrome.

Nucala generated sales worth £2.01 billion in 2025, increasing 15% year over year at constant exchange rate. The drug remains one of the key top-line drivers for GSK.

GSK’s Zacks Rank & Stocks to Consider

GSK currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Alkermes ALKS, Castle Biosciences CSTL and Immunocore IMCR, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Alkermes’ 2026 earnings per share (EPS) have increased from $1.54 to $1.91. Shares of ALKS have gained 26.1% over the past six months.

Alkermes’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 4.58%.

Over the past 60 days, Castle Biosciences’ loss per share estimates for 2026 have decreased from $1.06 to 96 cents. Shares of CSTL have surged 64.9% over the past six months.

Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 66.11%.

Over the past 60 days, Immunocore’s loss per share estimates for 2026 have decreased from 97 cents to 90 cents. Shares of IMCR have lost 3.1% over the past six months.

Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 53.96%.

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This article originally published on Zacks Investment Research (zacks.com).

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