Kamada gets FDA OK to begin phase 3 trials of API for congenital emphysema

By Lisa Kerner

Erie, Pa., March 9 - Kamada said the Food and Drug Administration has released its clinical hold status, approving the company's third phase of clinical trials for Alpha 1-Proteinase Inhibitor (API) for congenital emphysema, a disease caused by an inborn deficiency of Alpha 1 protein.

The drug, produced using the fourth fraction of human plasma, will be administered by inhalation rather than injection, according to a company news release.

"The FDA approval is a major step for the company toward debuting commercial distribution in the United States," chief executive officer David Tsur said in the release.

An estimated 200,000 people worldwide suffer from Congenital Emphysema, many of them undiagnosed, the release stated. Patients undergoing API treatment will require medication for the remainder of their lives.

Kamada is a Rehovot, Israel-based biopharmaceutical company that develops, produces and markets pharmaceuticals administered by infusion during emergency and trauma situations.

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