The FDA approved ADMA Biologics' intravenous immune globulin (IVIG) drug product Asceniv for the treatment of primary humoral immunodeficiency disease in adults and adolescents, the company reported. ADMA indicated that the drug, formerly known as RI-002, is expected to be launched in the second half of 2019. Shares in the drugmaker jumped as much as 70 percent on the news.
"We hope availability of Asceniv will help ameliorate a portion of the current shortages facing US IVIG supply," remarked CEO Adam Grossman. "Going forward, we believe this FDA approval better positions ADMA to further its mission to evaluate Asceniv in immune-compromised patients infected with or at-risk for respiratory syncytial virus infection," Grossman added.
The approval was based on data from a Phase III study that included 59 patients with primary humoral immunodeficiency disease who received regular infusions of Asceniv over the course of one year. Results for the trial's primary endpoint, which were announced in 2014, showed that no patients given Asceniv experienced a serious bacterial infection in the 12-month study period.
According to ADMA, the product's label will include a boxed warning about potential thrombosis and renal dysfunction or failure.
