GSK Secures FDA Clearance For Exdensur In Eosinophilic Asthma Treatment

A significant regulatory milestone has been achieved in the management of severe asthma, as the US Food and Drug Administration has greenlit GSK's latest therapeutic agent. The drug in question, Exdensur (depemokimab-ulaa), is now authorized as an add-on maintenance option for patients aged 12 years and older suffering from severe asthma with an eosinophilic phenotype.

**What Sets This Approval Apart**

The distinction lies in Exdensur's dosing frequency and mechanism of action. This represents the inaugural ultra-long-acting biologic formulation specifically designed for eosinophilic asthma management, requiring administration only twice annually. This reduced dosing regimen addresses a critical need in severe asthma management, particularly for patients with eosinophil-driven disease.

**Global Regulatory Progress**

GSK's momentum extends beyond US borders. The European regulatory pathway has already progressed favorably, with a positive Committee for Medicinal Products for Human Use (CHMP) opinion recently rendered. Full European approval is anticipated during the opening quarter of 2026. Concurrently, the company has initiated regulatory filings in additional jurisdictions, with China and Japan among the key markets under review.

**Clinical Context**

Eosinophilic asthma represents a distinct subset of severe asthma characterized by elevated eosinophil levels in the airways. This phenotype-specific approach allows for more targeted therapeutic intervention in patients whose disease pathophysiology is driven by eosinophilic inflammation, potentially improving outcomes compared to broader asthma management strategies.

The approval underscores GSK's continued expansion in the respiratory and immunology therapeutic area, addressing unmet treatment needs in severe asthma management.