News
Kamada seeks FDA license to market liquid Alpha-1 IV product
Business Wire
NESS ZIONA, Israel—The Israeli biopharmaceutical company Kamada has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its lead clinical candidate, intravenous alpha-1 antitrypsin, for the treatment of Alpha-1 Antitrypsin Deficiency.
Kamada’s still-unnamed IV augmentation therapy comes in liquid form, with no need for mixing. If it receives FDA approval and is marketed in the United States, it will be competing with the three current Alpha-1 IV therapies, Aralast, Prolastin and Zemaira, all of which are mixed with a sterile diluent before infusions.
Kamada CEO David Tsur said, “The submission of our AAT-IV BLA is an important milestone for Kamada, as it positions us one step closer to bringing our product to the US and European markets. We believe that the data supporting the BLA for our innovative AAT-IV are strong and we look forward to working with the FDA to bring this important and advantageous therapy to market for the benefit of the patient population.”
