Wyeth Warns of Drug Delays

Wyeth will submit the results to the FDA by midyear, necessitating an extra six months of review. Test results reveal a "favorable safety profile," and the FDA might act by year-end, the company said. Later this year, Wyeth will seek approval in the European Union and also in the U.S. for the added indication of treating the brittle-bone disease.

Meanwhile, Wyeth said it expects a delay until July for the FDA's decision on Pristiq for treating the symptoms of menopause. The FDA had been scheduled to rule next week. Wyeth, which previously predicted a third-quarter launch, said its submission of additional tests necessitated the extended review. Pristiq will be made at the Puerto Rico plant.

Pristiq also is being developed as an antidepressant. Although the FDA granted conditional clearance in January, Wyeth has said it's asking the agency to review additional tests of a lower-dose version for treating depression.

Over time, the projected launch has gone from mid-2007 to late 2007 or early 2008. On Thursday, Wyeth said the FDA is expected to review the drug during the first quarter of 2008. Executives said the wait will be worthwhile because tests of the lower-dose drug show fewer side effects.

Meanwhile, the experimental kidney-cancer drug Torisel is scheduled for FDA action in July , following the agency's decision two weeks ago to take 90 more days to review additional test data.

Executives said they expect the FDA to rule in August on the schizophrenia drug bifeprunox, and they predict they will file an application by year-end for the menopause-symptoms drug Aprela.

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