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FDA Alerts
Genetic and Congenital

FDA accepts priority review for leniolisib for treatment of APDS

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The U.S. Food and Drug Administration has accepted for priority review a New Drug Application (NDA) for leniolisib, an oral, selective phosphoinositide 3-kinase delta (PI3Kδ) inhibitor, to treat the rare primary immunodeficiency activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older in the US, according to a press release. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 29, 2023, aligned with a Priority Review classification.

The submission was supposed by phase II/III study data of leniolisib, which met its co-primary endpoints of reduction in index lymph node size and correction of immunodeficiency in the target population.

Read the full press release here.

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