Looks like good news for LLY and could be a plus for the whole sector. Fast track status. Looks like drug has the added benefit of reducing "bad" choloesterol levels which should make it a real blockbuster. As usual, looks like Murphy was wrong (about the limitations, this time).
>>Thursday November 20, 4:37 pm Eastern Time
Company Press Release
Lilly's Evista - raloxifene hydrochloride - Recommended for FDA Marketing Clearance for Prevention of Osteoporosis
INDIANAPOLIS--(BW HealthWire)--Nov. 20, 1997--Eli Lilly and Company announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration recommended Evista(R) (raloxifene hydrochloride) for marketing clearance for the prevention of postmenopausal osteoporosis.
The committee's recommendation, although not binding, will be considered by the FDA in its final review of the New Drug Application (NDA) submitted by Lilly in June 1997. That same month, based on the potential therapeutic significance of Evista, the FDA placed the drug on a six-month, or priority, review schedule. This classification does not ensure a decision within that time frame, nor is it a guarantee of approval.
Evista is among the first in a new class of drugs called selective estrogen receptor modulators (SERMs). SERMs are being studied for their selective ability to act like estrogen in some tissues but not in others.
More than 13,000 women in 28 countries have participated in Evista clinical trials to date. Interim data from these trials, released in June and presented to the FDA advisory committee today, showed that Evista prevented bone loss in the total body, lower spine and hip and also significantly increased bone mineral density in these regions when compared with calcium-supplemented placebo. Studies to assess Evista's ability to prevent fractures in postmenopausal women with osteoporosis are ongoing and involve more than 7,700 women worldwide.
Investigators are also studying Evista's effects on serum lipids (cholesterol and fatty substances). In clinical trials, Evista significantly reduced LDL, or ''bad'' cholesterol, and total cholesterol when compared with placebo. Evista also significantly reduced serum fibrinogen. It did not affect total HDL, or ''good'' cholesterol, or triglycerides.
Evista did not stimulate uterine or breast tissue. In clinical trials, women taking Evista did not differ from women taking placebo with respect to adverse uterine tissue effects, uterine bleeding, or breast swelling, tenderness or pain. In addition, clinical studies reveal that, when compared with placebo, Evista did not increase the risk of endometrial or breast cancer.
The majority of side effects reported during clinical trials were mild. The most commonly reported side effects were hot flashes and leg cramps; however, discontinuation rates were low and comparable with placebo. In addition, Evista was associated with an increase in venous thromboembolic events (VTEs), similar to reported rates for hormone replacement therapy (HRT).
As a woman makes the natural transition through menopause and her ovaries stop producing estrogen, she faces an increasing number of long-term health risks, among them osteoporosis. According to the National Osteoporosis Foundation, 28 million Americans, 80 percent of them women, are at risk of developing osteoporosis, a disease in which bones become fragile and are more likely to break. During the first five years after menopause, a woman can lose as much as 25 percent of her bone mass.1 If not prevented or left untreated, osteoporosis can progress painlessly until a bone breaks.
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. << |
