FDA Postpones Freedox Vote
A US Food and Drug Administration advisory panel has postponed giving a recommendation on whether Upjohn's lazaroid compound Freedox (tirilazad mesylate) should be granted approval in the USA for the treatment of severe aneurysmal subarachnoid hemorrhage.
The panel said that it wanted more information on the effectiveness of the drug. As part of its submission, Upjohn had only one clinical study which showed efficacy in reducing mortality in men. Reportedly, none of the studies showed any benefit for women.
Jerry Mitchell, vice chairman of the board and president of Upjohn Labs, said that the company "believes that tirilazad has potential for treating aneurysmal subarachnoid hemorrhage and it was clear that the committee is interested in that potential," adding that the company "will work diligently with the FDA to resolve the unanswered questions."
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