FDA Endorses Osteoporosis Treatment

INDIANAPOLIS (AP) - Federal regulators on Friday endorsed a natural bone-building hormone that appears to be an effective treatment for women with osteoporosis, the brittle bone disease that afflicts millions of older Americans.

Forteo, manufactured by Eli Lilly and Co. (NYSE:LLY - news), won the unanimous endorsement of the U.S. Food and Drug Administration (news - web sites)'s advisory committee as a treatment for osteoporosis in postmenopausal women. The committee issued a 5-5 split vote on its recommendation as a treatment to increase bone mass in men with the disease.

``Today's review of Forteo by the FDA advisory committee is an important step in delivering on our promise to remain at the forefront of osteoporosis research and in providing innovative solutions for the millions of Americans who suffer from this disease,'' said John Lechleiter, Lilly's executive vice president for pharmaceutical products.

Forteo is a bone formation agent that work primarily to stimulate new bone formation by increasing the number and activity of bone-forming cells called osteoblasts.

A study published by The New England Journal of Medicine (news - web sites) in May showed that Forteo stimulated new bone formation, significantly lowered fracture risk and significantly increased bone mineral density compared with placebo in postmenopausal women with osteoporosis during an average of 18 months' treatment.

Forteo can be administered only by daily injections.