Adma Biologics gets FDA nod for Asceniv

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Adma Biologics gets FDA nod for Asceniv

By Sandra Levy - 04/22/2019
Adma Biologics has received the Food and Drug Administration’s blessing for Asceniv (immune globulin intravenous, human – slra 10% liquid), formerly referred to as RI-002.

Asceniv is indicated for the treatment of primary humoral immunodeficiency disease, or PIDD, in adults and adolescents 12-to-17 years old.

The company anticipates having the product available for commercial launch during the second half of 2019.

“We are excited about this significant achievement in receiving FDA approval for Asceniv, a novel, patented IVIG product that we feel is a necessary addition to existing available therapies for patients who suffer from [PIDD]. We hope availability of Asceniv will help ameliorate a portion of the current shortages facing U.S. IVIG supply,” ADMA Biologics president and CEO Adam Grossman said, adding, "There are approximately 250,000 [PIDD] 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.”