Tuesday, July 24, 2007

Wyeth - Pristiq: more depression

Wyeth shares dropped Tuesday after the company said the Food and Drug Administration did not approve its drug Pristiq as a treatment for night sweats and hot flashes associated with menopause.

The FDA sent Wyeth an approvable letter, saying it wants more data about the drug's side effects, which include cardiovascular problems. The agency said Wyeth should hold a clinical trial lasting as least one year to provide that data.

Wyeth said it will work with the FDA to provide the data, and said it plans to keep developing the drug.

Goldman Sachs analyst James Kelly said it may not make sense for Wyeth to keep developing Pristiq, as it will file a new drug application for a "better" drug, Aprela, that treats the same ailments later this year.

Aprela contains hormone therapy, Kelly said, and as a result it is probably more effective than Pristiq, which does not.

More at BusinessWeek

No comments: