Pharming Group receives positive CHMP opinion for immunodefocoency treatment

 

• If approved, Joenja® (leniolisib) would become the first approved treatment in the European Union for activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS), a rare primary immunodeficiency
• Decision based on Phase II/III clinical data demonstrating statistically significant impact on measures of immune dysregulation and immunodeficiency
• Final European Commission decision expected in Q2 2026

https://www.biospace.com/press-releases/pharming-group-receives-positive-chmp-opinion-for-joenja-leniolisib-for-the-treatment-of-apds-in-adult-and-pediatric-patients-12-years-and-older