FDA Approves Lilly's Forteo for Osteoporosis

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FDA Approves Lilly's Forteo for Osteoporosis

WASHINGTON (Reuters) Nov 26 - Eli Lilly and Co.'s Forteo (teriparatide), a

drug that stimulates new bone formation in patients with osteoporosis, won

approval from US health officials on Tuesday.

The Food and Drug Administration approved Forteo for the treatment of

osteoporosis in men and post-menopausal women who are at high risk for a

fracture, agency spokeswoman Bradbard said.

Forteo is the first approved treatment for osteoporosis that stimulates new

bone formation, an FDA statement said. Other drugs work to stop or slow bone

loss.

Forteo " has the capacity to turn on bone-forming cells...and to actually

make more bone. That's very appealing in patients with severe osteoporosis, "

Dr. Ethel Siris, director of the Toni Stabile Center for the Prevention and

Treatment of Osteoporosis at Columbia-Presbyterian Medical Center, said in

an interview. Siris also is a consultant for Lilly.

In animal studies with Forteo, there was an increase in the number of rats

developing osteosarcoma, according to the FDA.

" In human studies, no osteosarcomas were reported, but the possibility that

humans treated with (Forteo) may face an increased risk of developing this

cancer cannot be ruled out, " the FDA statement said. " This safety issue is

highlighted in a black box warning in the drug's label for health

professionals and explained in a brochure, called a Medication Guide, for

patients. "

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