Panel Supports New Use for Evista

Advisers to the Food and Drug Administration recommended Tuesday that Eli Lilly's(LLY Quote - Cramer on LLY - Stock Picks) osteoporosis drug Evista could be used to prevent some breast cancers.

The advisory committee voted 8 to 6 to endorse Evista for reducing the risk of invasive breast cancer in postmenopausal women who have osteoporosis. It also voted 10 to 4 for Evista to reduce the risk of invasive breast cancer in postmenopausal women who are at high risk for the disease. There was one abstention for each vote.

The FDA isn't bound by recommendations from its outside medical advisers, but it usually follows them. Citing American Cancer Society data, Lilly said about 180,000 U.S. women are diagnosed with invasive breast cancer each year.

The only FDA-approved drug for preventing the breast-cancer indications covered by Tuesday's vote is the generic tamoxifen. This drug carries a black box warning -- the FDA's toughest alert -- about uterine cancer, blood clots and stroke. These side effects occur in less than 1% of women, and the FDA says the benefits for most women outweigh the risks.

In one big clinical trial comparing tamoxifen with Evista, those conditions weren't as frequent with the Lilly drug.

A prominent side effect for Evista is a risk of blood clots in the legs and lungs. An FDA staff report issued last week said medical advisers needed to weigh whether Evista's benefits outweighed the risks of blood clots or death by stroke.

The report said Lilly's clinical trials generally excluded women who were at "deep risk" for blood clots and stroke. "It is unlikely the incidence of serious Evista adverse events will be less in general use than in the clinical trials," it said.

Evista is approved for both treating and preventing osteoporosis. It has been one of Lilly's biggest drugs, contributing sales of $1.05 billion last year. However, sales have been growing at only 1% to 2% annually since 2004. For the first half of 2007, sales were up 5% from last year to $542 million.