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
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