Belgium’s Solvay and partner Wyeth’s hopes of launching bifeprunox, their investigational compound for schizophrenia, next year in the USA have been scuppered by US regulators.
The companies have received an action letter from the US Food and Drug Administration which rejects their New Drug Application for bifeprunox, an atypical antipsychotic reviewed for the acute treatment of schizophrenia, as well as the maintenance of stable adult patients. The agency stated that bifeprunox demonstrated effectiveness in the long-term maintenance study, and indicated that a second study could be sufficient to support a maintenance claim for the compound, but has concluded that “efficacy data, when compared to reference drugs, were not sufficient for approval”.
There was some more bad news for Wyeth after the firm and partner ViroPharma announced that they will discontinue dosing patients in Phase II trial of its hepatitis C treatment candidate HCV-796, citing safety concerns. The decision follows a review by a joint safety review board which found that around 8% of patients receiving HCV-796 in combination with pegylated interferon and ribavirin had elevated liver enzymes. read more
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