Adma Biologics announces FDA approval for Asceniv sBLA

Adma Biologics (ADMA) announced the FDA has approved the company’s supplemental biologics license application submitted under section 351 of the Public Health Service Act for Asceniv. The FDA approval represents the final study report for the Pediatric assessment as required in the post marketing commitment. Additionally, the approval provides for a revision of Asceniv’s prescribing information to expand the primary humoral immunodeficiency indication to pediatric patients two years of age and older. Previously, the indication for Asceniv was restricted to PI patients aged 12 years and older.