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FDA committee recommends new drug for osteoporosis

Moreland

In this story:

November 20, 1997
Web posted at: 8:10 p.m. EST (0110 GMT)

WASHINGTON (CNN) -- An advisory panel to the U.S. Food and Drug Administration voted Thursday to recommend approval of a new drug to fight osteoporosis that also appears to reduce a woman's chance of developing breast cancer by 60 percent.

The drug, known generically as raloxifene, would be marketed by Eli Lilly & Co. as Evista. It is the first of a new class of drugs that fight thinning bones and, although it has yet to be proven conclusively, may also protect older women against heart disease.

Research shows that the drug increases bone density by 2 percent.

Osteoporosis affects about 25 million Americans, mostly older women during or after menopause who are subject to debilitating hip and spinal fractures. If approved by the FDA, which usually accepts the advice of its panels, raloxifene could be on the market within six months.

Raloxifene is a selective estrogen receptor modulator (SERM), a new class of drugs that mimic the effects of estrogen in some parts of the body -- for example its protective effects on bone -- while inhibiting "bad" effects such as an increased risk of cancer.

Lilly says Evista fits into the same pocket in estrogen receptors as estrogen does in bone, heart, and other cells, but it has a special side chain that prevents it from fitting into breast and uterine estrogen receptors, which may prevent tumor formation.

No spotting, bleeding or swelling

Trials have shown raloxifene can increase bone density, a measure of bone strength, by about 2 to 3 percent. That is less than the benefits offered by hormone therapy or by rival drug Fosamax, which is made by Merck & Co. Inc.

But Lilly says raloxifene does not cause spotting or bleeding. Lilly also claims that raloxifene spares women the breast swelling, tenderness and pain that often accompany hormone therapy. And it may spare them the increased cancer risk as well.

Lilly claims that two-year data showed that women taking Evista had a 60 percent lower probability of getting breast cancer than expected, but not all the experts were impressed.

"When considering breast cancer risk reduction, on average, two years of exposure is relatively short term," says FDA reviewer Eric Colman said.

Drugs like raloxifene are often taken for as long as 20 years, and the National Women's Health Network called for longer studies of the drug, saying it was especially concerned about the cancer risk. But the group also said it supports its approval for osteoporosis prevention.

Raloxifene does not relieve symptoms of menopause such as hot flashes, and it is unclear how beneficial it may be against heart disease. Studies show that it lowers LDL, or so-called bad cholesterol, as well as total cholesterol levels, tempting some to conclude that it may reduce the chance of heart disease and stroke.

Drug's effect on heart disease uncertain

But Robert Kreisberg of the Baptist Health System in Birmingham, Alabama, said, "It's yet to be proven that this drug has a cardioprotective effect."

Fosamax also builds bone mass, but some women cannot tolerate it. Hormone replacement therapy is often taken to help prevent bone-thinning, but it too carries risks for many women.

"I think there are a lot of women who have said no to estrogen who would say yes to raloxifene," said Dr. Nelson Watts of Emory University. "I'm excited that we have scientific data and an option to individualize treatment."

Correspondent Rhonda Rowland and Reuters contributed to this report.

 
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