The company's AATD-IH drug could become the first inhalable treatment for congenital emphysema.
Kamada Ltd. (TASE: KMDA) has obtained US Food and Drug Administration (FDA) approval for a Phase II/III clinical trial of AATD-IH, the inhalable version of its AAT drug for treatment of Alpha-1 antitrypsin deficiency for the treatment of congenital emphysema. The company believes that if its Phase II/III clinical trial currently underway in Europe is successful, the FDA may recognize the data, due in late 2013, for the purpose of the FDA study, together with the data due from the Phase II study.
Recognition of these data should shorten the obtaining of marketing approval of AATD-IH from the FDA. If approved, the drug will be the first inhalable treatment for congenital emphysema, caused by deficiency of the Alpha-1 antitrypsin protein.
Published by Globes [online], Israel business news - www.globes-online.com - on October 14, 2012
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