Dyax obtains FDA complete response letter for hereditary angioedema drug

Dyax has received a complete response letter from the FDA pertaining to the company’s biologic license application for DX-88 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 (REMS) and additional information with respect to the chemistry, manufacturing and controls section of the biologic license application (BLA). The letter does not include requirements for any additional clinical trials for approval of DX-88.

Dyax said that it 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 an REMS as part of its response.

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 and notify Dyax of when it expects to render a decision on the approvability of DX-88.

Gustav Christensen, president and CEO of Dyax, said: Dyax’s clinical, regulatory and manufacturing groups have already begun work on providing all necessary information to complete the BLA approval process. We will continue to work with the FDA to ensure that DX-88 will be available to patients suffering from this rare, potentially fatal genetic disorder as quickly as possible.