Octaplas Approval Includes Comparative Postmarket Study Requirements
This article was originally published in The Pink Sheet Daily
FDA filing was supported entirely by data and postmarketing studies from Europe, where the drug has been approved for over two decades. Octapharma’s pooled plasma treatment minimizes risk for bad infections and a severe complication of clotting disorder treatments, CBER says.
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Patients with the most severe type of disease were all randomized to treatment with the study drug, which may have had a negative impact on outcome, the Israeli company suggested.