FDA Asks For More Info on Dyax Candidate DX-88
Fri, 03/27/2009 - 4:45am
CAMBRIDGE, Mass. (AP) — The Food and Drug Administration wants more information about Dyax Corp.'s drug candidate DX-88 but won't require the company to conduct more tests, Dyax said late Thursday. Dyax said the FDA asked for a plan to evaluate and mitigate risks of the drug. The agency also requested more data on the chemistry, manufacturing and controls of DX-88. The product is intended to treat acute attacks of hereditary angioedema, a protein deficiency disease that can cause dangerous swelling under the skin. Last month, an FDA panel recommended that the drug be approved in a vote of six to five, with two panelists abstaining.