India, Sept. 25 -- Pharming Group N.V. (PHAR) announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) seeking approval of lower doses of Joenja (leniolisib) for children aged 4 years and older who weigh between 13 kg and 27 kg with activated phosphoinositide 3-kinase delta syndrome (APDS).
The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2027.
If approved, Joenja would become available to eligible children aged 4 years and older with APDS who weigh at least 13 kg.
The sNDA follows the FDA's recent approval of Joenja for children aged 4 to 11 years with APDS who weigh at least 27 kg.
The applicatio...