Pharming Says FDA Accepts sNDA for Lower-Dose Joenja in Children With APDS
MT Newswires Live09-25
Pharming (PHAR) said Friday the US Food and Drug Administration accepted its supplemental new drug application seeking approval of lower doses of Joenja for children aged four and older who weigh between 13 kg and 27 kg and have activated phosphoinositide 3-kinase delta syndrome, a rare genetic immunodeficiency disease.
The application received priority review, with an FDA target action date of Jan. 30, 2027.
Pharming said the filing is supported by positive phase 3 data showing reduced lymphadenopathy and increased naive B cells after 12 weeks in children ages four to 11.
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