Pharming's Joenja Edges Closer To Becoming First EU-Approved APDS Treatment After Positive CHMP Opinion With European Commission Decision Due Q2 2026
Benzinga Newsdesk 7 months ago
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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 immunodeficiencyDecision based
- 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