Wyeth’s bifeprunox “not approvable”

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. It is the second regulatory set back for Wyeth in recent days; the firm's menopause therapy Pristiq was deemed "approvable" in July (1"The Pink Sheet," July 30, 2007, p. 11)...