Pharming’s Joenja (leniolisib) Receives the US FDA’s Approval as First Treatment for Activated Phosphoinositide 3-Kinase Delta Syndrome
Shots:
- The US FDA has approved Joenja (selective PI3Kδ inhibitor) for APDS in adult & pediatric patients aged ≥12yrs. The product is expected to be available in the US in early April & will be available for shipment in mid-April
- The approval was based on the P-II/III trial evaluating Joenja (70mg, BID) vs PBO in 31 patients. The 12wk. results showed the clinical efficacy of Joenja & were significant in the co-1EPs that assessed improvement in lymphoproliferation as measured by a decrease in lymph node size & increase in naïve B cells thus reflecting the impact on immune dysregulation & normalization of immunophenotype
- The MAA of leniolisib is under the EMA’s review & opinion is expected in H2’23. The company also plans for regulatory approvals in the UK, Canada, Australia & Japan
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
