What's Happening?
The U.S. Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) by GSK as an add-on maintenance treatment for severe asthma characterized by an eosinophilic phenotype in patients aged 12 and older. This approval is based on data from
the SWIFT-1 and SWIFT-2 phase III trials, which demonstrated significant reductions in asthma exacerbations with depemokimab compared to placebo. The treatment, administered twice yearly, showed a 58% and 48% reduction in annualized asthma exacerbations in the respective trials. Depemokimab is designed to provide sustained protection from exacerbations with fewer doses, potentially improving patient outcomes and reducing healthcare system burdens.
Why It's Important?
The approval of Exdensur represents a significant advancement in the treatment of severe asthma, particularly for patients with an eosinophilic phenotype. With an estimated 2 million Americans living with severe asthma, this new treatment option could improve quality of life by reducing the frequency of exacerbations and hospital visits. The twice-yearly dosing schedule may enhance patient adherence and convenience, addressing a common barrier to the use of biologics. This development could also lead to broader adoption of biologic treatments in asthma care, potentially reducing healthcare costs associated with frequent exacerbations and emergency care.
What's Next?
Following the FDA approval, GSK plans to continue its global rollout of Exdensur, with regulatory submissions under review in regions including Europe, China, and Japan. The company aims to expand the use of depemokimab for other respiratory diseases with underlying type 2 inflammation. As healthcare providers and patients become more familiar with this treatment, it may lead to increased adoption and integration into standard asthma care protocols. The success of Exdensur could also encourage further research and development of long-acting biologics for other chronic conditions.
