The FDA informed the company that it will most probably require a dose-ranging study on subcutaneously administered DX-88 in order to support the company's application for approval.
Dyax, along with its partner Genzyme Corporation, is currently evaluating how best to respond to the FDA's suggestion in a timely manner. However, the company indicated that the production of additional data is likely to delay the company's previous guidance of an anticipated 2007 regulatory approval date.
“The FDA wants data to ensure that the current 30mg 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.”