Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma
GlaxoSmithKline PLC (GSK)
US:NYSE Investor Relations:
gsk.com/en-gb/investors
Company Research
Source: Business Wire
Exdensur is the first and only ultra-long-acting biologic with twice-yearly dosing approved for patients with severe asthma with an eosinophilic phenotypeApproval based on SWIFT trials showing significantly lower rate of annualized asthma exacerbations in patients receiving depemokimab versus placeboSWIFT data included reduction in exacerbations requiring hospitalization and/or emergency department visits with depemokimabAn estimated 2 million Americans live with severe asthma and 50% continue to experience frequent exacerbations and hospitalizations requiring novel solutions PHILADELPHIA--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older.The FDA approval of Exdensur is based on data from the SWIFT-1 and SWIFT-2 phase III trials. In these s
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