New Drugs Approved In April


The FDA approved Asceniv, developed by ADMA Biologics, Inc. (ADMA) on April 1 for the treatment of Primary Humoral Immunodeficiency Disease (PIDD or PI) in adults and adolescents.

Asceniv, a novel, intravenous immune globulin or IVIG is manufactured from human blood and contains naturally occurring polyclonal antibodies.

The company anticipates the commercial launch of the drug during the second half of 2019.

The drug comes with a boxed warning of thrombosis and renal dysfunction or failure, headache, sinusitis, diarrhea, gastroenteritis viral, nasopharyngitis, upper respiratory tract infection, bronchitis, and nausea.