GSK has announced positive opinions from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending the approval of two new potential medicines for respiratory diseases. 

Depemokimab has been recommended as add-on maintenance treatment for severe asthma with type 2 inflammation (12+) and as an add-on therapy with intranasal corticosteroids for adult patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP). 

If approved, depemokimab will be the first ultra-long-acting biologic in the EU to treat respiratory diseases. 

Positive opinion is based on four Phase III trials with statistically significant and clinically meaningful primary endpoints across severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). 

Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology & Inflammation R&D, GSK said: “Many patients with severe asthma continue to face frequent exacerbations, hospital visits and exposure to chronic oral corticosteroids, highlighting the need for new therapies that deliver durable control with less treatment burden. In just two doses a year, depemokimab could help redefine care for millions of patients.” 

Meanwhile, Nucala (mepolizumab), a monoclonal antibody targeting interleukin-5 (IL-5), was recommended as an add-on maintenance treatment for uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils. 

The positive opinion based on the MATINEE Phase III trial showing significant reduction in COPD exacerbations versus placebo in addition to inhaled triple therapy. 

Kaivan Khavandi, SVP & Global Head, Respiratory, Immunology & Inflammation R&D, GSK added: “People living with uncontrolled COPD with an eosinophilic phenotype continue to experience exacerbations that can lead to irreversible lung damage and avoidable hospitalisations and emergency department visits. Preventing these events is crucial to slowing the progression of disease and today’s CHMP recommendation brings us closer to providing Nucala to patients who are in need of new options.” 

The final European Commission decisions are expected in Q1 2026.

Diana Turner, Deputy Editor, DDW