GSK gets preliminary nod for two respiratory drugs in Europe

(Sharecast News) - GSK said on Friday afternoon that two of its respiratory medicines had received positive opinions from the European Medicines Agency's Committee for Medicinal Products for Human Use, bringing the company closer to potential approvals across severe asthma, chronic rhinosinusitis with nasal polyps and chronic obstructive pulmonary disease. The FTSE 100 drugmaker said the CHMP recommended approval of depemokimab as an add-on maintenance treatment for severe asthma with type 2 inflammation in adults and adolescents aged 12 and over, and as an add-on therapy for adults with severe chronic rhinosinusitis with nasal polyps whose disease is inadequately controlled by systemic corticosteroids and or surgery.

A European Commission decision was expected in the first quarter of 2026.

If approved, depemokimab would become the first and only ultra-long-acting biologic in Europe for respiratory diseases, with a twice-yearly dosing regimen.

The positive opinion was based on four phase three trials, including the SWIFT and ANCHOR studies, all of which met their primary or co-primary endpoints with statistically significant and clinically meaningful results.

In pooled SWIFT data, depemokimab reduced clinically significant asthma exacerbations by 54% over 52 weeks compared with placebo, while exacerbations requiring hospitalisation or emergency care were reduced by 72%.

In the ANCHOR trials in nasal polyps, depemokimab significantly improved nasal polyp scores and nasal obstruction symptoms at one year.

GSK said the treatment was well tolerated, with a safety profile comparable to placebo.

"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," said Kaivan Khavandi, senior vice-president and global head of respiratory, immunology and inflammation R&D at GSK.

"Today's positive CHMP opinion means that depemokimab could become the first and only ultra-long-acting biologic approved in Europe for the treatment of severe asthma with type 2 inflammation and CRSwNP.

"In just two doses a year, depemokimab could help redefine care for millions of patients."

Separately, the CHMP also recommended approval of Nucala, GSK's IL-5-targeting monoclonal antibody mepolizumab, as an add-on maintenance treatment for adults with uncontrolled COPD characterised by raised blood eosinophils despite treatment with inhaled triple therapy.

The European Commission decision on that indication was also expected in the first quarter of 2026.

GSK said the recommendation was based on results from the MATINEE phase three trial, which showed a statistically significant reduction in the annualised rate of moderate or severe COPD exacerbations with mepolizumab compared with placebo when added to inhaled triple therapy.

The trial reported a rate ratio of 0.79, with reductions also seen in exacerbations requiring emergency department visits or hospitalisation, where mepolizumab achieved a rate ratio of 0.65 versus placebo.

Adverse event rates were similar between treatment and placebo groups.

"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," Khavandi said.

"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."

Nucala is already approved in Europe for four indications, including severe asthma and chronic rhinosinusitis with nasal polyps, and received US approval for COPD in May.

At 1351 GMT, shares in GSK were up 0.33% at 1,827p.

Reporting by Josh White for Sharecast.com.