Pharming Group N.V. (PHAR) on Thursday said the U.S. Food and Drug Administration has accepted its resubmitted supplemental New Drug Application (sNDA) for Joenja to treat children aged 4 to 11 years with activated phosphoinositide 3-kinase delta syndrome (APDS), a rare primary immunodeficiency.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of October 24, 2026.
The resubmission follows a Complete Response Letter (CRL) received on January 30, 2026, and includes additional data requested by the FDA regarding analytical methods used for production batch testing.
If approved, Joenja would be the first FDA-cleared treatment for children with APDS in the United States, the company said.
The sNDA seeks approval of 40 mg and 50 mg twice-daily doses for pediatric patients weighing 27 kilograms or more. Pharming said it plans to submit a separate sNDA in the second half of 2026 seeking approval for lower doses for patients weighing less than 27 kilograms.
Joenja is currently approved in multiple countries and regions, including the United States, Europe, and Japan, for APDS patients aged 12 years and older.
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