Pharming’s MAA Application for Leniolisib Receives Approval by the EMA to Treat Activated Phosphoinositide 3-Kinase Delta Syndrome
Shots:
- The MAA was granted based on the data from the P-II/III study evaluating the safety & efficacy of leniolisib in adolescents & adults (≥12yrs.) with APDS. The MAA submission was also supported by the data from an extension clinical trial evaluating leniolisib for the same indication
- The results demonstrated a reduction in lymph node size along with an increase in the percentage of naïve B cells in patients with APDS. Additionally, the safety data depicted that leniolisib was well tolerated by all patients
- Leniolisib is a small molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K, that functions by inhibiting the production of PIP3 which is a cellular messenger activating AKT & cell function regulator
Ref: PR Newswire | Image: Pharming
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