The European Medicines Agency (EMA) has initiated a review of GlaxoSmithKline’s (GSK.L) request to expand the use of its asthma drug Nucala (mepolizumab) as an additional treatment for chronic obstructive pulmonary disease (COPD) in patients with an eosinophilic phenotype, the British pharmaceutical company announced on Monday.
Clinical Trial Results Support Approval
This regulatory review follows positive clinical trial results published in September 2024, which demonstrated that COPD patients treated with Nucala, in combination with an inhaled maintenance therapy, experienced a lower annualized rate of moderate or severe exacerbations over 104 weeks compared to those receiving a placebo.
COPD, a chronic lung condition that leads to restricted airflow and breathing difficulties, is often referred to as ‘smoker’s lungs’ due to its prevalence among cigarette smokers in Western countries.
Nucala’s Role in COPD Treatment
Nucala is a monoclonal antibody that targets and inhibits interleukin-5 (IL-5), a key regulator of eosinophils—a type of white blood cell that, when produced in excess, can cause lung inflammation and worsen respiratory conditions.
If approved, Nucala would become the first biologic treatment with a convenient monthly dosing schedule for COPD patients. The disease affects an estimated 390 million people worldwide, with over 40 million cases in Europe alone.
Market Potential and GSK’s Growth Strategy
Originally approved in 2015 for a specific type of severe asthma, Nucala has since expanded its indications. The drug’s sales grew 12% in 2024, generating approximately £1.78 billion ($2.3 billion)—accounting for 6% of GSK’s total revenue.
As GSK continues to strengthen its respiratory treatment portfolio, the potential approval of Nucala for COPD would mark a significant milestone in advancing biologic therapies for chronic lung diseases, offering a new treatment option for millions of patients in need.
