The company plans to launch the protein replacement therapy in 2010.
Drug development company Kamada Ltd. (TASE: KMDA) today announced that the US Food and Drug Administration (FDA) has completed the preliminary review of the company's Biological License Application (BLA) for its intravenous AAT (Alpha-1 Antitrypsin) for replacement therapy in individuals lacking this protein, resulting in the respiratory disease bronchiectasis.
Kamada successfully completed the Phase III clinical trial of intravenous AAT in April 2008 and submitted the BLA in June 2009. The company plans to launch the drug in the second half of 2010, after obtaining FDA marketing approval.
FDA officials will come to Israel to examine Kamada's production facilities and laboratories as part of authorization process.
Kamada's share rose 11.1% in morning trading to NIS 32.21.
Published by Globes [online], Israel business news - www.globes-online.com - on August 4, 2009
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