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FDA Approves ASCENIV™, a Novel Intravenous Immune Globulin
Approved for Use in the Treatment of Primary Humoral Immunodeficiency Disease ("PIDD" or "PI") in Adults and Adolescents (12 to 17 Years of Age)FDA Approval
About this update from Adma Biologics Inc
[{"type":"text","content":"Approved for Use in the Treatment of Primary Humoral Immunodeficiency Disease (\"PIDD\" or \"PI\") in Adults and Adolescents (12 to 17 Years of Age)FDA Approval Triggers Funding up to $27.5M from Existing Credit Facility with Perceptive AdvisorsRAMSEY, N.J. and BOCA RATON, Fla., April 01, 2019 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ:ADMA) (\"ADMA\" or the \"Company\"), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces that the U.S. Food and Drug Administration (\"FDA\") has approved ASCENIV™, Immune Globulin Intravenous, Human - slra 10% Liquid, formerly referred to as RI-002. ASCENIV™ is an Intravenous Immune Globulin (\"IVIG\") drug product for the treatment of Primary Humoral Immunodeficiency Disease (\"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 (\"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. There were zero SBIs during the 12-month study period. The manuscript and data set describing the results are published by Dr. Richard Wasserman, et al in the Journal of Clinical Immunology (2016) Volume 36: 590-599. The approved labeling will include a boxed warning about potential thrombosis and renal dysfunction or failure, as well as the most common adverse events observed in the pivotal study, which were headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.\"We are excited about this significant achievement in receiving FDA approval for ASCENIV™ a novel, pate...