Pharming Reports the EC approval of Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS)

Shots:

• The EC has approved Joenja for pts (≥12yrs.) with APDS syndrome across all 30 EEA states. Initial launch is expected in Germany in Q3’26, with further launches anticipated subject to completion of national reimbursement negotiations
• Approval was based on P-II/III trial of Joenja vs PBO in 31 APDS pts (≥12yrs.), 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.
• Joenja (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

PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com