FDA Needs More Data On Univax' WinRho
The US Food and Drug Administration's Center for Biologics Evaluation has sent a Product License Application letter to Univax and its collaborator, Rh Pharmaceuticals, asking for additional information on completed clinical trials and manufacturing issues related to WinRho SD (polyclonal antibody preparation) to treat immune thrombocytopenic purpura and the prevention of Rh isoimmunization.
No additional clinical trials have been requested and no substantive issues were raised in the FDA letter, according to the company, which added that the agency did not raise any issues which had not been discussed in detail at the Blood Products Advisory Committee meeting. Anticipating the requests, the company has already prepared most of the submission and feels the letter indicates the review is on track. WinRho SD is already on the market in Canada for Rh isoimmunization.
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