Hereditary Angioedema

FDA permission granted to resume DX-88 clinical trials

Published in Medical Letter on the CDC and FDA, July 4th, 2004

Dyax Corp. (DYAX) reported that the U.S. Food and Drug Administration (FDA), upon further review of recently submitted data, has given the company permission to resume phase II clinical trials involving its recombinant protein DX-88.

Dyax recently announced that DX-88 clinical studies were placed on clinical hold by the FDA for reasons unrelated to observations in humans, and pending the agency's further review of preclinical animal data.

This review was promptly conducted, and the clinical hold has been removed. While DX-88 clinical studies continue, Dyax and Genzyme Corporation (GENZ) will collaborate closely with the FDA to design additional...

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Source: Medical Letter on the CDC and FDA (2004-07-04)

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