Pharming says FDA accepts Joenja pediatric sNDA, sets Jan. 30, 2027 PDUFA date
PHAR•The FDA accepted Pharming’s supplemental new drug application for a Joenja label expansion covering children with APDS aged 4 and older who weigh 13 to 27 kg, granting Priority Review and setting a Jan. 30, 2027, action date.
1. Priority review granted
Pharming said the FDA accepted its pediatric sNDA for Joenja and granted Priority Review. The proposed label expansion would cover children aged 4 and older who weigh 13 to 27 kg; the current U.S. indication covers children aged 4 to 11 who weigh at least 27 kg. The FDA’s PDUFA action date is Jan. 30, 2027.
