FDA approves Asceniv to treat primary humoral immunodeficiency disease
ADMA Biologics, Inc. announces that the 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 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.
ADMA anticipates the commercial launch of Asceniv during the second half of 2019.
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