newsfilter
← Latest News
Business Wire·

Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma

GSK
  • The FDA approved Exdensur (depemokimab-ulaa) as the first ultra-long-acting biologic for severe asthma with an eosinophilic phenotype, allowing twice-yearly dosing.
  • Approval covers adult and pediatric patients aged 12 years and older as an add-on maintenance treatment for severe asthma.
  • Clinical data from SWIFT-1 and SWIFT-2 trials showed a 58% reduction in annualized asthma exacerbations for SWIFT-1 and a 48% reduction for SWIFT-2 compared to placebo.
  • Patients receiving depemokimab had significantly fewer exacerbations requiring hospitalization or emergency department visits, with a 72% reduction in the annualized rate of clinically significant events in pooled analysis.
  • Approximately 2 million Americans live with severe asthma, with half experiencing frequent exacerbations despite current treatments.
  • Depemokimab features an extended half-life to suppress type 2 inflammation with reduced dosing frequency, potentially improving adherence and reducing health system burdens.
  • The drug was well-tolerated in trials, showing similar rates and severity of side effects compared to placebo.
  • Common adverse reactions included upper respiratory tract infection, allergic rhinitis, influenza, arthralgia, pharyngitis, and injection site reactions.
  • Hypersensitivity reactions, including anaphylaxis, are a potential risk, and the drug should not be used to treat acute asthma symptoms.
  • Physicians must avoid abrupt discontinuation of corticosteroids upon initiating Exdensur therapy to prevent withdrawal symptoms or unmasking of suppressed conditions.
  • Patients with pre-existing parasitic infections require treatment before starting Exdensur, and therapy should be paused if infections do not resolve with anti-helminth treatment.
  • Safety data for pregnant women is insufficient to identify drug-associated risks, and transmission of the drug across the placenta may lead to prolonged infant exposure.
  • Exdensur received a positive CHMP opinion in Europe, with an approval decision expected in Q1 2026.
  • Regulatory submissions for depemokimab are under review in other global markets, including China and Japan.
  • GSK is evaluating depemokimab in additional phase III trials for chronic rhinosinusitis with nasal polyps, EGPA, HES, and COPD.