REG-Pharming announces U.S. FDA acceptance and Priority Review of sNDA for lower doses of Joenja® to treat children with APDS
The FDA accepted Pharming's sNDA and granted Priority Review for lower doses of Joenja (leniolisib) to treat children aged 4 and older weighing 13-27 kg with APDS, with a PDUFA target action date of January 30, 2027. The submission is backed by an open-label Phase III study in children aged 4 to 11 showing reduced lymphadenopathy and increased naive B cells over 12 weeks.
Key figures
- Drug Name
- Joenja (leniolisib)
- Phase Of Trial
- Phase III
- Pdufa date
- January 30, 2027
- Review type
- Priority Review
- Patient population
- children aged 4+ weighing 13-27 kg with APDS
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