FDA Approval: Depimokimab in Severe Eosinophilic Asthma

The FDA has approved depimokimab as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents. The authorization immediately affects patients who continue to exacerbate despite guideline-directed inhaled corticosteroids and additional controllers, offering durable protection with fewer administrations.

Depimokimab is approved for adults and adolescents aged 12 years and older and is dosed as a subcutaneous injection every 26 weeks. The monoclonal antibody suppresses blood eosinophils by targeting Th2‑type pathways that drive eosinophilic disease, reducing key biologic drivers of exacerbations. The six‑month dosing interval distinguishes depimokimab from prior biologics that require monthly or quarterly administrations.

In pooled analyses of the SWIFT-1 and SWIFT-2 trials, researchers found ~54% reduction in the annual rate of clinically significant exacerbations versus placebo. The trials also showed sustained eosinophil suppression and a marked reduction in severe exacerbations requiring emergency department care or hospitalization.