India Pharma Outlook Team | Friday, 20 February 2026
Global pharma leader GSK has secured European Commission approval for Exdensur (depemokimab), a new treatment for patients living with severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).
The decision clears Exdensur as an add-on maintenance therapy for adults and adolescents aged 12 and older with severe asthma driven by type 2 inflammation who remain uncontrolled despite high-dose inhaled corticosteroids and another controller. It is also approved as an add-on to intranasal corticosteroids for adults with severe CRSwNP when systemic steroids or surgery fail to deliver relief.
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The approval is backed by results from the Phase III SWIFT and ANCHOR trials. Both studies met their primary or co-primary endpoints, showing statistically significant and clinically meaningful improvements when depemokimab was added to standard care. The trials also confirmed sustained efficacy with a twice-yearly dosing schedule.
“The approval of Exdensur in the EU means there is now an innovative ultra-long-acting option that offers sustained efficacy over 6 months to protect patients from severe asthma exacerbations and the debilitating symptoms associated with CRSwNP. Exdensur may help redefine care for the millions of patients living with these persistent and burdensome conditions, supporting them in achieving their treatment goals with just two doses a year,” said Kaivan Khavandi of GSK.
Asthma affects more than 42 million people across Europe, with up to 10% facing severe disease. Exdensur’s high IL-5 binding affinity and extended half-life allow lasting suppression of type 2 inflammation with just two doses per year, offering new hope for better disease control.
