The FDA wants Dyax to produce more data on its experimental therapy for hereditary angiodema. The drug developer said it would have to revise its timeline for FDA approval and will probably have to conduct a dose-ranging study of DX-88. Dyax and drug partner Genzyme say they are studying their options. A Phase III study is expected to wrap up soon.
"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."
- here's the UPI report for more info