FDA Approves Expanded Label for ASCENIV for PI Patients 2 Years and Older

The U.S. Food and Drug Administration (FDA) has approved ADMA Biologics’ supplemental biologics license application (BLA) submitted under section 351(a) of the Public Health Service Act for ASCENIV. Approval represents the final study report for the pediatric assessment as required in the post-marketing commitment. Additionally, it provides for a revision of ASCENIV’s prescribing information to expand the primary humoral immunodeficiency (PI) indication to pediatric patients 2 years of age and older. Previously, the indication for ASCENIV was restricted to PI patients aged 12 years and older.

“This expanded label for ASCENIV allows ADMA to actively address the treatment needs of younger PI and immune compromised patients earlier in their treatment journey,” said Adam Grossman, president and chief executive officer of ADMA. “In the periods ahead, we look forward to continuing to expand the utilization of ASCENIV by offering our differentiated and patented immune globulin as an FDA-approved treatment option for immune compromised pediatric patients in need.”

“We proudly recognize the extraordinary collaboration of the PI disease community and dedicated physicians, along with the courage and commitment of the children and families whose participation was essential in driving this clinical program forward,” said Kaitlin Kestenberg, chief operating officer and senior VP of compliance. “Enrolling in and successfully completing these complex trials is a significant achievement, and this FDA approval reflects the strength of the clinical and operational execution of the devoted ADMA team.”