Evista receives FDA approval!!!!!!!!!
Wednesday December 10, 7:01 am Eastern Time
Company Press Release
Lilly's Evista Cleared for Marketing for the Prevention of Osteoporosis in Postmenopausal Women
INDIANAPOLIS--(BW HealthWire)--Dec. 10, 1997--Eli Lilly and Company today announced that the United States Food and Drug Administration (FDA) granted the company permission to market Evista(R) (raloxifene hydrochloride) 60 mg tablets for the prevention of osteoporosis in postmenopausal women. Osteoporosis affects more than 28 million Americans, most of them women.
Evista, the first in a class of new drugs called selective estrogen receptor modulators (SERMs) to be approved by the FDA for marketing for the prevention of osteoporosis, is being studied for its selective ability to act like estrogen in some tissues but not in others.
Evista should be available in pharmacies by early January.
''Millions of postmenopausal women at risk for osteoporosis will soon have a new option for stopping bone loss and preserving their strength,'' said August M. Watanabe, M.D., Lilly executive vice president, science and technology, and president of Lilly Research Laboratories, a division of the company.
As a woman makes the natural transition through menopause and her ovaries stop producing estrogen, she faces an increasing number of health risks, including osteoporosis, a disease that causes bones to become fragile and break. During the first five years after menopause, a woman can lose as much as 25 percent of her bone mass. If left untreated, this condition can cause painful, debilitating fractures. Widely accepted risk factors for osteoporosis include Caucasian or Asian descent, slender body build, early estrogen deficiency, smoking, alcohol consumption, low calcium diet, sedentary lifestyle and family history of osteoporosis.
According to the National Osteoporosis Foundation, a woman's risk of hip fracture (often related to osteoporosis) is equal to her combined risk of breast, uterine and ovarian cancer. Following a hip fracture, there is a 10-20 percent mortality rate during the next six months.
The effects of Evista on fracture risk are not yet known. However, studies to evaluate the ability of Evista to prevent fractures in postmenopausal women who already have osteoporosis are ongoing and involve more than 7,700 women worldwide.
The company has submitted applications to market Evista in more than 30 countries around the world.
Efficacy in the prevention of osteoporosis
The FDA reviewed data from 50 studies conducted in 28 countries to establish the safety and efficacy of Evista for the prevention of postmenopausal osteoporosis. More than 12,000 women have participated in the clinical program to date.
A total of 1,764 postmenopausal women participated in pivotal Phase 3 osteoporosis prevention studies. In two studies, women were randomly assigned to take Evista or placebo. In the third study, women took Evista, placebo or estrogen replacement therapy. All the women took calcium supplements. In each study, Evista was superior when compared with placebo in preventing bone loss in the lumbar spine and hip. These pivotal clinical trials also showed that Evista builds bone, although to a lesser extent than estrogen.
''Clinical studies show that Evista acts like estrogen in the skeletal system and stops the loss of bone that occurs after menopause,'' said investigator Robert Lindsay, M.D., Ph.D., chief of internal medicine at Helen Hayes Hospital in New York and chief of its Clinical Research Center. ''The preservation of healthy bone is critical in preventing the onset of osteoporosis and protecting a woman during her postmenopausal years.''
Adverse events
As with most drugs, Evista was associated with some side effects, the majority of which were reported as mild. A rare but serious side effect associated with Evista was an increase in venous thromboembolic events. The most-commonly observed side effect was hot flashes. Women taking Evista reported a higher rate of hot flashes than women taking placebo (24.6 percent compared with 18.3 percent); however, discontinuation rates due to hot flashes were about 2 percent in both groups. Women taking Evista also reported a higher rate of leg cramps than women taking placebo. The leg cramps, generally reported by women as ''mild,'' did not cause them to discontinue Evista therapy.
Key safety data
Given postmenopausal women's concerns about stimulation of the reproductive tissues, the clinical program for Evista was designed to assess the drug's effects on both uterine and breast tissue. Safety information, pooled from nine separate studies and gathered from more than 10,000 women who have been in the clinical trials for up to 30 months, demonstrates that Evista did not increase the risk of endometrial or breast cancer.
''I look forward to offering patients an attractive, new option with Evista,'' said Ethel Siris, M.D., director of the Toni Stabile Center for the Prevention and Treatment of Osteoporosis, Columbia-Presbyterian Medical Center. ''The ease of use of Evista, coupled with its favorable side effect profile, should enable women to comply with therapy so that they may realize Evista's benefits.''
The occurrence of adverse uterine tissue effects and vaginal bleeding were no different between women taking Evista and women taking placebo in clinical trials. In contrast, women taking hormone replacement therapy (HRT) had an increased incidence of spotting and bleeding. There were also no differences between women taking Evista and those taking placebo with respect to breast pain. In contrast, women taking HRT had an increased incidence of breast pain when compared with patients taking Evista.
Investigators also studied the effects of Evista on serum lipids (cholesterol and fatty substances) in a six-month study of 390 postmenopausal women who were assigned to Evista, placebo or HRT. Evista produced significant reductions in LDL, or ''bad'' cholesterol, and total cholesterol. Evista did not increase HDL, or ''good'' cholesterol, when compared with placebo. In addition, Evista significantly reduced serum fibrinogen and did not change triglycerides. In the ongoing osteoporosis prevention studies, 24-month data are consistent with these findings.
In keeping with the company's commitment to bringing new therapeutic options to patients in a timely manner, Lilly is planning to conduct long-term studies to assess the efficacy of Evista for postmenopausal women at risk for heart disease or breast cancer.
Lilly is a global research-based pharmaceutical corporation headquartered in Indianapolis, Ind., that is dedicated to creating and delivering innovative pharmaceutical-based health care solutions that enable people to live longer, healthier and more active lives. Women's health is a key area in which the company is focusing its efforts.
Evista(R) (raloxifene hydrochloride, Lilly)
(Editors: Full prescribing information for Evista is available for no charge through Business Wire's News on Demand fax service. To obtain a copy, simply call toll-free (888) 286-8107, reference document No. 4410).
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Contact:
Eli Lilly and Company
Elisabeth Ritz, Lilly, 317/277-1172
Jessica DiSalle, for Lilly, 212/598-3696
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