FDA approves drug for breast cancer

WASHINGTON - Eli Lilly & Co., the maker of the osteoporosis medicine Evista, won approval to use the drug to reduce risks of invasive breast cancer in certain women.

The Food and Drug Administration cleared the expanded marketing for postmenopausal women who have osteoporosis or are predisposed to developing the cancer, Lilly said yesterday in a statement. Tamoxifen, a generic drug, was previously the only treatment approved to prevent breast cancer.

The approval will help Evista stand out in the increasingly competitive market for drugs to prevent and treat osteoporosis, a condition in which bones become weak or brittle, analysts said. An FDA advisory panel recommended approval in July after company studies suggested that Evista may work as well as tamoxifen, with fewer dangerous side effects.

"Any way to differentiate your product from competitors is useful," said Jon LeCroy, an analyst at Natexis Bleichroeder in New York, in an Aug. 30 phone interview. "I doubt it's going to be a huge, huge driver." Investors should determine whether the new use increases prescription volume before buying shares, LeCroy said.

Lilly, based in Indianapolis, also will highlight a warning that women who have strokes after taking the drug are at a higher risk of dying. The warning had been added earlier this year in a less noticeable section of the packaging.

Lilly fell 36 cents yesterday to $56.82 on the New York Stock Exchange. Lilly has risen 9 percent this year.

Evista, first approved in the United States in 1997, is the drug maker's fifth-biggest product, with $1.05 billion in revenue last year.

About 1 in 8 women will develop invasive breast cancer at some point in their lives, according to the American Cancer Society. About 178,000 US women will be diagnosed with the disease this year, and 40,000 will die from it. Only lung cancer is more common among women.

An estimated 10 million Americans over age 50 have osteoporosis, and almost 34 million are at risk of developing the disease because of low bone mass, according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

A pill that helps prevent both osteoporosis and breast cancer will be a valuable tool for millions of women, Lilly said. Some women are reluctant to take tamoxifen, a generic drug, because of the potential for dangerous side effects such as cancer of the uterus.