ADMA Biologics : FDA Okays Asceniv, Intravenous Immune Globulin

(RTTNews) - ADMA Biologics, Inc. (ADMA) said 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 or "IVIG" drug product for the treatment of Primary Humoral Immunodeficiency Disease or "PIDD" or "PI" in adults and adolescents (12 to 17 years of age).

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

The ASCENIV pivotal Phase III clinical study followed FDA guidance for treatment of patients with PI. The study enrolled fifty-nine patients with PI at nine sites across the U.S. in which study patients received regular infusions of ASCENIV over the course of one year. The trial's primary endpoint evaluated the rate of Serious Bacterial Infections or "SBI" in patients treated with ASCENIV.

Secondary endpoints included time to first SBI and to first serious infection, days on antibiotics, days off school or work due to infections, all confirmed infections of any kind, and hospitalizations due to infection.