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Wyeth/Solvay bifeprunox hits a snag

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Wyeth and Solvay will pursue approval of the atypical antipsychotic bifeprunox for the maintenance of stable adult patients with schizophrenia despite receiving a "not approvable" letter for the drug, Wyeth announces Aug. 10. The companies appear less likely to pursue an indication for the acute treatment of schizophrenia in the near-term, however. "FDA makes it clear that absent a compelling reason, the lower efficacy in the acute use does not support approval," Senior VP Joseph Mahady states during a same-day conference call. The action letter acknowledges the efficacy of bifeprunox in the maintenance setting and outlines a path forward for its approval, which will include completion of a second maintenance study. Approval in that setting could be set back one to two years, the firm said...
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