Lilly gets FDA nod on new osteoporosis drug use

CHICAGO (Reuters) - Eli Lilly & Co (LLY.N) said on Friday that it had won approval to market its blockbuster osteoporosis drug to post-menopausal women who are at high risk for invasive breast cancer.

The company also said U.S. health regulators had extended the use of the drug, known as Evista, to help reduce the risk of the aggressive form of breast cancer in post-menopausal women who have the bone-thinning disease.

However, the drug will also contain a stronger warning of side effects that can include death by stroke.

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

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

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

SERMs are drugs used to treat osteoporosis that also appear to prevent breast cancer by reducing estrogen in breast tissue. Estrogen in breast tissue can drive some types of breast cancer.

"This data's been unfolding for the last few years, so it's not as if physicians are not aware of this, but now Lilly will be able to market it," said Deutsche Bank analyst Barbara Ryan.

In 2007, Evista sales were flat with the prior year, she noted. "Our view is that this (approval) may begin to deliver some growth of maybe 10 to 20 percent," she said.

That would equate to roughly $100 million to $200 million in incremental revenues annually. "But it doesn't dramatically move the needle at Lilly," Ryan said. "So it's not momentous, but we'll watch the scripts like everyone else, and maybe we'll be surprised."

Lilly, whose other products include antidepressant Prozac and erectile dysfunction drug Cialis, reported second-quarter revenue of $4.63 billion.

Earlier this year, Lilly updated the label for Evista to include safety information from a clinical trial that evaluated post-menopausal women, some of whom were suffering from coronary artery disease and some who were 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 that women at risk for stroke should receive the drug only after careful evaluation.

A company spokeswoman said the so-called black-box warning did not preclude the company from conducting direct-to-consumer advertising.

The company presented studies of 37,000 women that compared Evista with a placebo or tamoxifen, which has been used about 25 years to treat patients with advanced breast cancer.

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 were down 33 cents at $56.85 in morning New York Stock Exchange trade. Their price has ranged from $51.13 to $60.63 during the past 52 weeks.

(Reporting by Debra Sherman)