17 May 2006 - Dyax Corp. announced an update on regulatory pathway for the DX-88 program in hereditary angioedema (HAE). This program was transferred from the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) division to the Center for Drug Evaluation and Research (CDER) division as a result of the FDA's 'Plan for Consolidation.' In meetings with CDER, following this reassignment, the FDA has indicated that Dyax will likely need to complete some incremental clinical work, most probably a dose-ranging study on subcutaneously administered DX-88 to secure final approval.
At this time, Dyax and its partner, Genzyme Corporation, are evaluating options to address the FDA's suggestion in a timely manner. While Dyax expects that the process of responding to the FDA and providing additional data will likely affect the previous guidance of an anticipated 2007 regulatory approval date, Dyax can not provide additional guidance until the overall regulatory submission package and specific new data requirement have been discussed and further reviewed by the FDA. This new request will not affect the estimated second half of 2006 timeline for completion of the ongoing EDEMA3, Phase III clinical trial.
"The FDA wants data to ensure that the current 30 mg fixed dose of DX-88 is in fact the optimal dose for subcutaneous administration," stated Tom Beck, President and Chief Operating Officer of Dyax. "The amount of additional data and analysis that might be necessary to address this requirement is currently being discussed with the FDA. However, it should be noted that the FDA has expressed no issues or concerns with the overall safety and activity of DX-88."
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