UK regulator MHRA approves GSK’s Nucala for adults with eosinophilic COPD uncontrolled on triple therapy, expanding biologic options in respiratory care.

news

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Nucala for the treatment of adults with eosinophilic chronic obstructive pulmonary disease (COPD) who remain uncontrolled despite triple inhaled therapy, marking a significant expansion of biologic treatment options in COPD management.

 

Targeting Persistent Inflammation

The approval enables use of Nucala as an add-on treatment for patients with raised blood eosinophil levels who continue to experience exacerbations despite optimal standard therapy. By targeting interleukin-5, Nucala reduces eosinophilic inflammation, a key driver of exacerbations in a defined COPD subpopulation. This decision reflects growing recognition of disease heterogeneity in COPD.

 

Strategic Expansion Beyond Asthma

Developed by GSK, Nucala has been widely used in severe eosinophilic asthma and other inflammatory conditions. Its approval in eosinophilic COPD strengthens GSK’s respiratory biologics portfolio and signals a broader industry shift toward precision medicine approaches in traditionally non-biologic respiratory diseases.

Need Help

Accelerate Your Launch Strategy

Planning a market entry or navigating complex regulations? Our healthcare strategists are ready to support your next milestone with precision and speed.

Speak to Our Experts