NEWS! - Lilly gets FDA OK to expand Evista labeling
Monday December 14, 4:13 pm Eastern Time
INDIANAPOLIS, Dec 14 (Reuters) - Pharmaceutical company Eli Lilly and Co. said Monday it has been granted government approval to include on the label of its osteoporosis drug, Evista, that there is a lower incidence of breast cancer in post-menopausal women taking the drug.
Evista was launched in the United States last January for the prevention in post-menopausal women of osteoporosis, a bone brittling disease. It is also approved for use in about 30 countries.
Lilly said the U.S. Food and Drug Administration just approved the inclusion of expanded breast safety information into the physician product label. Lilly cautioned, however, that the effectiveness of
Evista in reducing the risk of breast cancer has not yet been established over the longer term.
''We want to stress that this expanded label information is not a new indication, but rather validates the safety of Evista on breast tissue,'' the company said in a statement.
In studies reported late last week, researchers said Evista cut the cancer rate in half among women who had taken the drug over three years. Lilly had tested Evista, known generically as raloxifene, on
more than 10,000 women.
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