ADMA Biologics ASCENIV gets FDA approval
ADMA Biologics’ (NASDAQ:ADMA) ASCENIV has received FDA approval for the treatment of primary humoral immunodeficiency disease (PI) in adults and adolescents.
The approval is based on results of a pivotal Phase 3 clinical study of 59 PI patients who received regular infusions of ASCENIV over the course of one year. The trial’s primary endpoint was the rate of serious bacterial infections - none were reported during the 12-month study period.
ASCENIV is an intravenous immunoglobulin (IVIG) that contains naturally occurring polyclonal antibodies from normal source and donor plasma. ASCENIV is one of several programs ADMA is developing for immunodeficient individuals.
Addressing current shortages of IVIG in the U.S., Adam Grossman, president and CEO of ADMA, said, “there are approximately 250,000 PI patients diagnosed and living in the U.S., and we believe there is an opportunity to treat meaningful segments of this patient population with ASCENIV.”
ADMA anticipates commercial launch of ASCENIV during the second half of 2019.