FDA seeks further testing of Wyeth drug

By LINDA A. JOHNSON, AP Business WriterTue Jul 31, 11:06 PM ET
Federal regulators' demand for further testing of a nonhormonal drug for menopause symptoms should not delay approval of the same drug as a depression treatment, executives at drugmaker Wyeth said late Tuesday.
In a conference call to address concerns triggered by the Food and Drug Administration's decision to require a new study of the drug Pristiq, officials at Wyeth said they will work closely with the FDA to speed the drug's approval as the first nonhormonal treatment for menopause symptoms.
Wall Street apparently was reassured, and Wyeth shares, which had dipped 4 cents to $48.52 in regular trading, jumped 98 cents, or 2 percent, to $49.50 in after-hours trading.
The FDA said on July 16 that it wants more data on Pristiq's effects on the heart and liver, because a very small number of women in studies of the drug for menopause symptoms had serious heart or liver complications.
In one of Wyeth's four studies in postmenopausal women, two women in the group taking Pristiq had heart attacks and three needed procedures to repair clogged arteries, compared with none in the group taking dummy pills, Wyeth's chief medical officer, Dr. Gary Stiles, told analysts during a conference call Tuesday evening.
In that study, however, there were eight times as many women taking Pristiq as taking dummy pills, he said. He listed eight additional factors in Pristiq's defense, including that the five women with heart complications had long-standing heart disease.
"We do not believe that those (heart complications) are drug related," Stiles said, adding, "Women clearly liked the product."
Still, the FDA requested that Madison, N.J.-based Wyeth conduct a randomized, placebo-controlled clinical trial of one year or longer, a huge blow to Wyeth.
While Pristiq was tested on a total of 2,158 postmenopausal women, only 318 took it for a year or more, with another 604 taking it for six months, apparently leading the FDA to ask for more long-term data.
The request means Wyeth likely won't be able to reapply for approval of Pristiq as a menopause drug for about 18 months, and the agency will then have about six months to review the new data and reach a decision.
"We believe Pristiq is a safe, effective and much-needed nonhormonal therapy" for menopause, said Greg Norden, Wyeth's chief financial officer.
About 85 percent of menopausal women are bothered by symptoms such as mood swings, hot flashes and trouble sleeping — often for several years. Many were scared off hormone drugs when a 2002 federal study linked them to serious risks.
Norden said FDA officials have reassured the company the additional safety data required to get approval as a menopause symptom treatment will not hold up approval of Pristiq as a depression treatment.
"We continue to believe it will receive approval in the first quarter of 2008" for depression, Norden said.
The company had been counting on the drug's approval last week — or at least nothing more than a short delay — to help it rebound from a huge drop in sales of its Premarin and Prempro drugs after 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.
The two drugs were once the company's top sellers, bringing more than $2 billion in annual revenues early in the decade, when few drugs did so. Last year, sales were half as much.
Getting approval of Pristiq also is important to Wyeth because its top-selling drug, antidepressant Effexor XR, which had 2006 sales of $3.7 billion, loses patent protection in 2010.
___
On the Net: http://www.wyeth.com