EU gives GSK's Nucala green light for use in uncontrolled COPD

(Sharecast News) - Drugmaker GSK said on Friday that the European Commission has approved Nucala (mepolizumab) as an add‑on maintenance treatment for adults with uncontrolled COPD characterised by elevated blood eosinophils. GSK said mepolizumab would be used alongside standard triple therapy of an inhaled corticosteroid, a long‑acting beta2‑agonist and a long‑acting muscarinic antagonist.

The decision was supported by results from its phase III MATINEE trial, where mepolizumab delivered a "clinically meaningful and statistically significant" reduction in the annualised rate of moderate and severe exacerbations compared with a placebo on top of standard care in COPD patients with an eosinophilic phenotype.

GSK also highlighted that Nucala was the first biologic with pre‑specified phase III data showing a reduction in exacerbations leading to emergency‑department visits and hospitalisations versus placebo.

Kaivan Khavandi, global head of GSK's respiratory, immunology and inflammation R&D unit, said: "For the first time, adults with uncontrolled COPD characterised by raised blood eosinophils in the EU will have the option for a monthly biologic shown to significantly reduce exacerbations, which can lead to irreversible lung damage, hospitalisations and emergency department visits. Nucala could offer relief to the millions of Europeans who need additional options beyond inhaled triple therapy to manage their COPD."

Reporting by Iain Gilbert at Sharecast.com