Shots:
- The US FDA has accepted sNDA & granted priority review to leniolisib for the treatment of children (4-11yrs.) with activated phosphoinositide 3-kinase delta (APKD) syndrome (PDUFA: Jan 31, 2026); regulatory review is ongoing in the EEA, Japan & Canada
- sNDA was supported by a P-III trial in APKD pediatric pts (4-11yrs.), which showed reduced lymphadenopathy & increased naïve B cells over 12wks. & was further backed by safety data from 8mos. of treatment
- Leniolisib (PO), a PI3Kẟ inhibitor marketed under the brand name Joenja in the US, is also being investigated in 2 P-III trials for APDS in children & 2 P-II trials for primary immunodeficiencies with immune dysregulation
Ref: Pharming | Image: Pharming | Press Release
Related News:- Daiichi Sankyo and AstraZeneca Receive the US FDA’s Priority Review for Enhertu + Perjeta to Treat HER2+ Breast Cancer
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
