FDA Delays Wyeth Osteoporosis Pill, Again

Bernie Poussot wanted to be ceo - now he has to earn his keep. First, he hears that Teva unexpectedly starts shipping generic versions of Wyeth's best-selling heartburn drug (see the Protonix item below). Now, the FDA has, for the second time this year, issued an approvable letter for Viviant, which would be used to prevent bone loss in post-menopausal women.

This is a big problem for Wyeth, which hoped to combine Viviant with estrogen in a pill called Aprela, which would be used to reduce hot flashes. So, now that drug is also delayed. The drugmaker has forecast $2 billion in sales for the two drugs. This comes on top of repeated FDA decisions to postpone approval for two different versions of the Effexor antidepressant, which would be used to treat menopausal hot flashes and depression, respectively.

As far as Viviant is concerned, the FDA wants to see more analyses and discussion of the strokes and blood clots that occurred in some patients taking the med. In a statement, Wyeth says studies submitted on over the past two months show a favorable benefit-to-risk ratio, and weren't reviewed as part of the FDA's action. The drugmaker added that the agency hasn't requested any new studies, but the FDA did identify "certain issues concerning data collection and reporting and requested additional source documents."