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FDA Approves Exdensur for Severe Asthma

Exdensur is the first and only ultra-long-acting biologic for patients with severe asthma with an eosinophilic phenotype.

GSK plc announced that the U.S. Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. The FDA approval is based on data from the SWIFT-1 and SWIFT-2 phase III trials. In these studies, depemokimab demonstrated sustained exacerbation reduction with two doses per year versus placebo, both plus standard of care.  Tre...

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