Healthy Skepticism Library item: 13157

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Publication type: news

Wyeth Pulls EU Menopause Drug Request
Yahoo Finance 2008 Mar 12
http://biz.yahoo.com/ap/080312/eu_wyeth_pristiq.html?.v=2

Abstract:

Wyeth Withdraws Request for EU Medicines Agency to Approve Menopause Drug Pristiq

Full text:

Wyeth has withdrawn a request to EU medicine regulators to approve a menopause drug that the U.S. last year refused to put on sale without further testing, the European Medicines Agency said Wednesday.

The EMA said the company plans more clinical studies after the agency questioned how the drug Pristiq treats hot flashes and other symptoms of menopause that affect the heart and liver. Wyeth can reapply for EU approval at a later date.

The U.S. Food and Drug Administration said last July that it wanted more data on Pristiq’s effects on the heart and liver, because very few women in studies of the drug had serious heart or liver complications.

The company has been counting on the drug to help it rebound from a huge drop in sales of its Premarin and Prempro drugs. The Women’s Health Initiative in 2002 linked Prempro to higher rates of heart attacks, strokes, breast cancer and other problems. Subsequent research has found the risks were generally limited to women taking hormones in their 60s and 70s.

Getting approval of Pristiq also is important to Wyeth because its top-selling drug, antidepressant Effexor XR, loses patent protection in 2010.

Wyeth shares fell $1, or 2.4 percent, to close at $40.65 Wednesday.