Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib

Pharming Group N.V. announces that the US Food and Drug Administration (FDA) has accepted for priority review its 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. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 29, 2023, aligned with a Priority Review classification. “The FDA’s acceptance for priority review of Pharming’s New Drug Application for leniolisib is a milestone that demonstrates our commitment to addressing unmet needs for patients with rare diseases." — Anurag Relan, MD | Chief Medical Officer Resources For further information, please contact: Media Relations Investor Relations Quick links

The release as fetched from its publisher. pharming.com ↗