Lilly gets FDA nod on new uses for osteoporosis drug

(Adds detail, background, stock price)

CHICAGO, Sept 14 (Reuters) - Eli Lilly & Co. (LLY.N) said on Friday U.S. health regulators extended the use of its blockbuster osteoporosis drug to post-menopausal women with osteoporosis who are also at high risk for breast cancer.

The drug Evista, known generically as raloxifene, is already approved for the prevention and treatment of osteoporosis, or bone thinning, in post-menopausal women.

Sales of the drug, a selective estrogen receptor modulator, topped $1 billion in 2006.

Earlier this year, Lilly updated the label for Evista to include safety information from a clinical trial that evaluated post-menopausal women suffering from coronary artery disease and post-menopausal women at increased risk for coronary disease.

The trial found no increase in the incidence of stroke but an increase in the incidence of death because of stroke.

Since the new label for Evista will include new uses and an expanded patient population, Lilly has worked with the FDA to revise the package insert. The insert will now emphasize that women with an active or past history of venous thromboembolism

-- potentially deadly blood clots -- should not take Evista and -- potentially deadly blood clots -- should not take Evista and that women at risk for stroke should receive the drug only after careful evaluation.

Lilly said that Evista, like the hormone estrogen, helps to fight osteoporosis. But Evista also blocks estrogen in breast tissue, Lilly said.

The company presented studies of 37,000 women that compared Evista with a placebo or tamoxifen, the only other medicine approved for breast cancer prevention.

Competing osteoporosis drugs include Merck & Co Inc.'s (MRK.N) Fosamax, and Roche Holding AG's (ROG.VX) and GlaxoSmithKline Plc's (GSK.L) Boniva.

Shares of Eli Lilly closed on Thursday at $57.18 on the New York Stock Exchange. They have traded between $60.63 and $51.13 during the past 52 weeks.

(Reporting by Debra Sherman)

((Editing by Steve Orlofsky; Reuters Messaging: debra.sherman.reuters.com@reuters.net; debra.sherman@reuters.com, 1-312-408-8134)) Keywords: LILLY OSTEOPOROSIS/

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