Wyeth bails on European Pristiq app

Wyeth just can't catch a break on Pristiq. The company withdrew its European application for the antidepressant, known as Ellefore in that market, because drug watchdogs there aren't convinced it works well enough to warrant approval.

Cleared for marketing as an antidepressant in the U.S., Pristiq is based on the active ingredient in Wyeth's now-off-patent blockbuster Effexor. Some doctors and researchers question whether the drug is much different from--or better than--other antidepressants already on the market.

As you know, Wyeth hasn't been much more successful at getting Pristiq the nod as a treatment for menopausal symptoms. It withdrew its European application for that indication in March, and last July it received the dreaded "approvable" letter from the FDA.

Now, the company is trying to figure out what to do in Europe. Wyeth really wants to get Pristiq/Ellefore onto the Euro-market, but it's not sure of the best strategy. One option could be seeking approval from individual countries one by one, rather than the EU as a whole. Analysts expect European approval to take at least two more years.

- here's Wyeth's release
- read the WSJ story

Related Articles:
Wyeth discounts Pristiq for big sales push
Me-too drugs now a tough sell
FDA OKs Wyeth's antidepressant Pristiq
Wyeth presents Pristiq data