The drugmaker and its partner, Solvay Pharmaceuticals, just disclosed that the agency issued an action letter, and that its bifeprunox isn't approvable at this time. Efficacy data wasn't sufficient, and the FDA wants more 'human metabolism' info, along with details of one patient death. Here's the Wyeth
statement:
"The FDA stated in the letter that bifeprunox demonstrated effectiveness in the long-term maintenance study and indicated that a second positive maintenance study could be sufficient to support a maintenance claim for bifeprunox. (We) believe bifeprunox offers distinct benefits for the long-term maintenance of patients with schizophrenia. (We) will meet with the FDA to discuss study design and to assess how this additional study combined with ongoing and planned studies might support a maintenance indication.
Although the FDA acknowledged that bifeprunox separated from placebo in two short-term studies in the acute setting, the agency concluded that the efficacy data, when compared to reference drugs, were not sufficient for approval. The agency also requested further information regarding human metabolism of bifeprunox, and additional information regarding a complex case of a patient who died while participating in one of the trials."
UPDATE: In a teleconference call, Wyeth's chief medical officer, Gary Stiles, says additional studies will mean required data won't be submitted until sometime next year or possibly 2009, depending upon the study. The drugmaker claims "it's not a safety issue at all." The patient death was due to "multi-organ failure."
Wyeth continues to suffer one setback after another. Also this morning, Wyeth and ViroPharma say they're discontinuing dosing a hepatitis C drug in a Phase 2 study, citing elevated liver enzyme levels in some patients after eight weeks or more of therapy. And last month, Wyeth received a second approvable letter for Pristiq, an updated version of Effexor menopausal hot flashes and depression.
In an investor note, Barbara Ryan, an analyst at Deutsche Bank, sums it up: "While our expectations for Wyeth's pipeline have been relatively modest, it is now clear to all that the combined commercial potential of these products won't be sufficient to replenish revenues that will be lost at the end of the decade to generics."
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[...] The U.S. Food and Drug Administration (FDA) let Wyeth and its partner, Solvay Pharmaceuticals, know that their newest schizophrenia drug, bifeprunox, needed further research to gain FDA approval. Pharmalot has the story. [...]
[...] The U.S. Food and Drug Administration (FDA) let Wyeth and its partner, Solvay Pharmaceuticals, know that their newest schizophrenia drug, bifeprunox, needed further research to gain FDA approval. Pharmalot has the story. [...]