ADMA Biologics announces FDA approval of BIVIGAM in pediatric patient setting

ADMA Biologics announced the U.S. Food and Drug Administration, FDA, has approved the Company’s supplemental Biologics License Application submitted under section 351 of the Public Health Service Act for BIVIGAM. 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 BIVIGAM’s prescribing information to expand the primary humoral immunodeficiency indication to pediatric patients 2 years of age and older. “We are pleased to announce that BIVIGAM has received FDA approval for treating PI in patients aged 2 years and older. Previously, the indication for BIVIGAM was restricted to PI patients aged 12 years and older,” said Adam Grossman, President and Chief Executive Officer of ADMA. “This expanded label for BIVIGAM allows ADMA to actively address the treatment needs of younger PI patients earlier in their treatment journey. In the periods ahead, we look forward to offering BIVIGAM as an FDA-approved treatment option for these pediatric PI patients,” concluded Mr. Grossman.