Clinical Trials
U.S. FDA grants approval to begin phase 3 trial of API in congenital emphysema patients
Published in Medical Letter on the CDC and FDA, April 12th, 2006
This announcement is the final approval required by the company to start the third phase of clinical trials with Kamada's flagship alpha 1-proteinase inhibitor drug. The clinical trial will include 50 patients from the U.S. and will follow the protocol submitted to and approved by the FDA.
API is used to treat congenital emphysema, a disease caused by an inborn deficiency of alpha1 protein. The drug is produced by Kamada using the fourth fraction of human plasma....
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