GlassiaTreatment for Alpha-1 Proteinase Inhibitor Deficiency
Update: Glassia (alpha1-proteinase inhibitor (human)) Now FDA Approved - July 1, 2010
BLA Submitted for AAT-IV
Kamada Submits U.S. Biologics License Application for the First Liquid, Ready to Use AAT for the Treatment of Alpha-1 Antitrypsin Deficiency
NESS ZIONA, Israel--(BUSINESS WIRE)--Jun 2, 2009 - Kamada (TASE:KMDA) – a bio-pharmaceutical company engaged in the development, manufacturing and marketing of specialty life-saving therapeutics, announced that it has submitted a Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") for its lead clinical candidate, intravenous alpha-1 antitrypsin ("AAT-IV"), for the treatment of Alpha-1 Antitrypsin Deficiency.
David Tsur, Chief Executive Officer of Kamada, 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."
About Kamada's IV-AAT
Kamada has developed a unique, high purity, liquid, ready-to-use human plasma derived AAT indicated for the treatment of Alpha 1 Deficiency. The product is produced using a sophisticated, chromatographic purification method.
Kamada is a public biopharmaceutical company (TASE:KMDA) developing, producing and marketing a line of specialty life-saving biopharmaceuticals. Licensed and marketed worldwide, several of these specialty therapeutics are currently undergoing advanced clinical trials. Additional information is available at www.kamada.com.
Posted: June 2009
- Kamada Wins FDA Approval for Glassia - a New Liquid, Ready-to-Use Treatment for Alpha-1 Antitrypsin Deficiency - July 6, 2010
- Kamada's Biologics License Application for IV-AAT to Treat Alpha-1 Antitrypsin Deficiency is Accepted for Review by the US Food and Drug Administration - August 4, 2009