The U.S. Food and Drug Administration (FDA) has officially approved Exdensur (depemokimab), an add-on biologic maintenance treatment for severe asthma characterized by an eosinophilic phenotype. This therapy is indicated for adult and pediatric patients aged 12 years and older, marking a significant milestone in managing chronic respiratory diseases through advanced biotechnology.
clinical efficacy and extended-action technology The approval is supported by data from the SWIFT-1 and SWIFT-2 Phase III clinical trials. Results demonstrated that Exdensur provides superior efficacy in preventing disease exacerbations:
- Exacerbation reduction: Achieved a significant 58% and 48% reduction in annualized asthma attack rates compared to the placebo group.
- Duration of action: Developed with an extended half-life, the therapy enables the sustained suppression of type 2 inflammation—the primary driver of the disease.
- Dosing frequency: Unlike traditional biologics requiring frequent administration, patients need only two doses per year to maintain continuous protection.
redefining the standards of patient care Leadership in respiratory and immunology R&D at the developing firm stated that the introduction of Exdensur could redefine care protocols for severe asthma patients. Reducing injection frequency not only enhances the quality of life for patients but also alleviates the cost and resource burden on the healthcare system.
Currently, beyond the U.S. market, this therapy has received a positive regulatory opinion in Europe, with approval decisions expected in other major global markets, including China and Japan, by early 2026.
Source: https://www.contractpharma.com/breaking-news/fda-approves-exdensur-for-severe-asthma/