The FDA has issued a non-approvable letter to Solvay and development partner Wyeth for bifeprunox, an antipsychotic for the treatment of schizophrenia. In order to gain approval, Wyeth and Solvay must conduct a second study of bifeprunox to prove long-term positive maintenance. The FDA also requested more data regarding human metabolism of bifeprunox. This is a second dose of bad news for Wyeth, which recently received an approvable letter for Pristiq [1].
"We believe that bifeprunox is a promising drug for the treatment of schizophrenia and that there is a need for new treatment options to help people with schizophrenia manage their disease," said Laurence Downey, M.D., President and CEO of Solvay Pharmaceuticals in a release. "We will work with the FDA to address its comments and pursue the approval of bifeprunox as soon as possible."
- see the release [2]
- read the Wall Street Journal article [3]
Related Articles:
Solvay expands development pact with Wyeth. Report [4]
FDA demands more data on Wyeth's Pristiq. Report [1]
Links:
[1] http://www.fiercebiotech.com/story/fda-demands-more-data-wyeths-pristiq/2007-07-24
[2] http://www.fiercebiotech.com/press-releases/press-release-wyeth-and-solvay-announce-receipt-fda-action-letter-bifeprunox
[3] http://blogs.wsj.com/health/2007/08/10/wyeth-pipeline-takes-another-leak/
[4] http://www.fiercebiotech.com/story/solvay-expands-development-pact-with-wyeth/2007-01-11