Dyax (DYAX) Receives Complete Response Letter from FDA Related to DX-88

March 26, 2009 4:23 PM EDT

Dyax Corp. (NASDAQ: DYAX) announced today that it has received a complete response letter from the U.S. FDA pertaining to the Company’s Biologic License Application for DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema. The letter outlines requirements for approval of DX-88 in this indication. Specifically, the FDA has requested submission of a Risk Evaluation and Mitigation Strategy and additional information with respect to the chemistry, manufacturing and controls section of the BLA. The letter does not include requirements for any additional clinical trials for approval of DX-88.

Dyax intends to fully address the FDA’s requests in a timely manner. Dyax previously submitted to the FDA a proposed Safe Use program, which Dyax will now be converting into a REMS as part of its response. The CMC questions are primarily focused on analytical methodologies and specifications and validation activities in support of drug product filling and packaging. Earlier this year, a pre-approval inspection of the manufacturing processes, sites and supporting quality systems was successfully completed.

Upon receipt of the Company’s response, the FDA will determine a revised review period based on guidelines defined in the Prescription Drug User Fee Act (PDUFA) and notify Dyax of when it expects to render a decision on the approvability of DX-88.

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