GSK's Exdensur gets green light from European Commission

(Sharecast News) - Drugmaker GSK said on Tuesday that the European Commission has approved its asthma and nasal polyps treatment Exdensur (depemokimab) for two separate indications. GSK said the regulator had cleared the drug as an add‑on maintenance therapy for adults and adolescents with severe asthma driven by type 2 inflammation who remain inadequately controlled despite high‑dose inhaled corticosteroids and another controller.

The FTSE 100-listed firm added that Exdensur was also approved as an add‑on treatment for adults with severe chronic rhinosinusitis with nasal polyps where systemic steroids or surgery have not provided sufficient control.

GSK said the decision was supported by data from its SWIFT and ANCHOR phase III trials, which showed sustained efficacy with a twice‑yearly dosing schedule. All four studies met their primary or co‑primary endpoints, with statistically significant and clinically meaningful results versus standard care alone.

Separately, GSK announced that it will begin the next phase of its previously announced share buyback programme, with the fourth tranche set to start immediately. The £2bn programme was scheduled to run until the end of the second quarter of 2026. The first three tranches have all been completed in line with their terms. GSK added that the fourth tranche will have a value of up to £450m.

As of 0830 GMT, GSK shares were up 1.33% at 2,213p.

Reporting by Iain Gilbert at Sharecast.com