Thursday, Dyax Corp. (DYAX), said it has received a complete response letter from the U.S. Food and Drug Administration, seeking additional details regarding the Biologic License Application for DX-88 for the treatment of acute attacks of hereditary angioedema.
The company said that the FDA has specifically requested for submission of a Risk Evaluation and Mitigation Strategy (REMS) and additional information with respect to the chemistry, manufacturing and controls or CMC section of the BLA.
The letter, however, did not include requirements for any additional clinical trials for approval of DX-88.
Following the disappointing turn of events, Dyax noted that it would fully address the regulatory body's requests in a timely manner. The company had previously submitted to the FDA a proposed Safe Use program, which it said it would now convert into 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 Chief Executive Officer of Dyax said, "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."
DYAX ended Thursday's regular trading at $2.75, up 1.85% or $0.05, on a volume of 0.34 million shares on the Nasdaq. In after-hours session, the stock lost 18.18% or $0.50, trading at $2.25.
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