UPDATE 1-Wyeth's Pristiq hit by FDA heart, liver concerns

Tue Jul 24, 2007 8:16am EDT

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NEW YORK, July 24 (Reuters) - Wyeth WYE.N on Tuesday said U.S. regulators are unwilling to approve its experimental drug Pristiq for hot flashes until the company resolves concerns about its potential to cause serious heart and liver problems.

Wyeth said the FDA has requested a new trial for the drug that could take a year or longer to complete, in order to better demonstrate the drug's safety in post-menopausal women.

It is one of Wyeth's most important experimental products and is also awaiting approval as a depression treatment.

The company is counting on Pristiq, a derivative of Wyeth's $3.5-billion-a-year Effexor antidepressant, to offset expected plunging sales of Effexor when its U.S. patent lapses in 2010. Some analysts have said Pristiq could post annual sales of up to $2 billion, if approved.

But the conditions linked to the FDA's so-called "approvable letter" for Pristiq must be satisfied before the drug can reach the market.

"The FDA said that before the application could be approved, it would be necessary for Wyeth to provide additional data regarding the potential for serious adverse cardiovascular and hepatic effects associated with the use of Pristiq" for hot flashes, Wyeth said in a release.

Wyeth said it remains committed to the drug as a treatment for hot flashes -- the waves of heat and sweat that are the most common symptoms of menopause.

(Reporting by Ransdell Pierson)

((Editing by Maureen Bavdek; Reuters Messaging: ransdell.pierson.reuters.com@reuters.net; 646-223-6034; ransdell.pierson@reuters.com)) Keywords: WYETH PRISTIQ/

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