Shares of Dyax took a beating today as the FDA refused to approve DX-88, the company's treatment for hereditary angioedema (HAE) attacks. HAE is a genetic disease that causes acute episodes of swelling in the extremities, the gastrointestinal tract, the genitalia, and in potentially life-threatening cases, the larynx.
Earlier, an expert FDA panel narrowly voted for approval of the drug despite concerns about the drug's effectiveness and side effects. At the time, staffers felt the need for new HAE therapies outweighed other issues. Now the FDA is asking for a Risk Evaluation and Mitigation Strategy (REMS) and additional information with respect to the chemistry, manufacturing and controls section of the BLA. Fortunately for Dyax, the agency is not asking for additional clinical trials to approve DX-88. A Cowen & Co analyst told Forbes that a the company will probably win approval for the drug in late 2009 or early 2010.
"Dyax's clinical, regulatory and manufacturing groups have already begun work on providing all necessary information to complete the BLA approval process," said Dyax CEO Gustav Christensen, President. "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."
- here's Dyax's release
- see the Forbes report