The European Commission on Tuesday approved GSK plc’s (NYSE:GSK) Exdensur (depemokimab) in two indications, including:

As an add-on maintenance treatment for severe asthma with type 2 inflammation, characterized by blood eosinophil count in adults and adolescents 12 years and older who are inadequately controlled despite high-dose inhaled corticosteroids plus another asthma controller.

As an add-on therapy with intranasal corticosteroids for adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery does not provide adequate disease control. 

The approval is based on data from the SWIFT and ANCHOR phase 3 trials, which showed sustained efficacy with a twice-yearly dosing regimen for depemokimab.

Trial Data

Each of the four trials met their primary or co-primary endpoints with statistically significant and clinically meaningful results, comparing the addition of depemokimab to standard of care versus standard of care alone.

Asthma affects more than 42 million people in ...