Friday, March 27, 2009

FDA wants more data from Dyax over DX-88

By Marc Songini

The U.S. Food and Drug Administration is looking for more information from Cambridge-based drug developer Dyax Corp. over its requested approval of its lead candidate, DX-88.

Dyax’s (Nasdaq: DYAX) DX-88 (ecallantide) is a recombinant small protein and selective plasma kallikrein inhibitor that is being evaluated as a treatment for acute hereditary angioedema, a rare and sometimes fatal disease.

Dyax announced this week the FDA has issued a letter requesting the submission of a Risk Evaluation and Mitigation Strategy, and additional data about the chemistry, manufacturing and controls section of the Biologic License Application. The letter didn’t request any additional clinical trials for approval of DX-88, stated Dyax.

Dyax intends to respond to the FDA’s requests in a “timely”  manner. Earlier this year, Dyax claimed it had successfully completed a pre-approval inspection of the manufacturing processes, sites, and supporting quality systems. After receiving Dyax’s response, the FDA will determine a revised review period based on guidelines in the Prescription Drug User Fee Act and notify Dyax when it plans to render a decision on DX-88.

Dyax’s clinical, regulatory and manufacturing units are already working on getting all the necessary information to complete the approval, stated president and CEO Gustav Christensen. A Dyax spokesperson declined to give any time estimate for how long the approval process would take.

Earlier this month, Dyax updated an existing loan to receive a $15 million tranche B loan. This was intended to support the costs of commercializing DX-88.