ADMA Biologics reports FDA approves Asceniv intravenous immune globulin

ADMA Biologics announced that the U.S. Food and Drug Administration has approved Asceniv Immune Globulin Intravenous, Human – slra 10% Liquid, formerly referred to as RI-002. Asceniv is an Intravenous Immune Globulin drug product for the treatment of Primary Humoral Immunodeficiency Disease, or “PIDD,” in adults and adolescents. 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 PI. We hope availability of Asceniv will help ameliorate a portion of the current shortages facing U.S. IVIG supply,” stated Adam Grossman, President and CEO of ADMA Biologics. “With the receipt of Asceniv’s FDA approval, ADMA, at its sole option, can elect to access up to an additional $27.5M of available funding from Perceptive Advisors under ADMA’s existing credit facility. This option remains available to the company through June 2020, and such funds could be used to support the launch of Asceniv, procure plasma raw material inventory, and begin construction on potential new plasma centers, as well as for general corporate activities,” concluded Grossman.
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