The application was made after the success in the Phase III clinical trial for AAT.
Kamada Ltd. (TASE: KMDA) today notified the Tel Aviv Stock Exchange (TASE) that it has submitted a Biological License Application (BLA) with the US Food and Drug Administration (FDA) for the company's Alpha-1 Antitrypsin (AAT) protein for the treatment of congenital emphysema.
The company filed the application following success in the Phase III clinical trial for AAT in the US. The company received notice of the success in April 2008.
Filing for a BLA is the final licensing stage in the US. Kamada will be able to begin US sales of AAT when the FDA approves the BLA and grants marketing approval.
Kamada's share rose 3.6% by midday to NIS 29.
Published by Globes [online], Israel business news - www.globes-online.com - on June 2, 2009
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