FDA Approves ADMA Biologics’ Asceniv for Treating Immunodeficiency

The FDA has given the go-ahead for ADMA Biologics’ Asceniv, a novel intravenous immune globulin drug used for treating primary humoral immunodeficiency disease (PIDD) in adults and adolescents 12 to 17 years of age.

The drug’s pivotal Phase III clinical study consisted of 59 patients with PIDD disease who received regular infusions of the treatment over one year, using the rate of serious bacterial infections (SBIs) as the primary endpoint. During the yearlong study, no SBIs occurred in patients.

ADMA Biologics said the drug should be ready for commercial launch during the second half of 2019.