Pharming Reports the CHMP Positive Opinion on Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta (APDS) Syndrome

Shots:

• The CHMP has recommended Joenja for the treatment of pts (≥12yrs.) with APDS syndrome, with EC decision expected in Q2’26, which, if positive, would be valid across all 30 EEA member states
• Opinion was based on P-II/III trial of Joenja vs PBO in 31 APDS pts (≥12 years), showing significant improvement in immune dysregulation & immunodeficiency, plus was also supported by long-term OLE data in 37 pts treated with Joenja for a median of 3yrs.
• Leniolisib (PO), a PI3Kẟ inhibitor, is under regulatory review in Canada & other countries for APDS treatment & is also being investigated in 2 P-II trials for primary immunodeficiencies with immune dysregulation

Ref: Pharming |   Image: Pharming  |   Press Release

Related News: Pharming Reports the US FDA’s sNDA Acceptance and Priority Review to Leniolisib for Activated Phosphoinositide 3-Kinase Delta Syndrome

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