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FDA Approves Expanded Use of Lilly's FORTEO(R) [teriparatide (rDNA origin) injection] to Treat Glucocorticoid-Induced Osteoporosis
Date:7/23/2009

e to 18 months of treatment by 7.2 percent at the lumbar spine, 3.6 percent at the total hip, and 3.7 percent at the femoral neck.(5)

"Until now, physicians and patients had only one class of approved therapy for the treatment of glucocorticoid-induced osteoporosis," said Kenneth G. Saag, M.D., MSc, professor of medicine and epidemiology at the University of Alabama in Birmingham. "The approval of teriparatide for this new indication offers healthcare providers and patients a new treatment option that effectively increases bone mineral density in a different way than anti-resorptives."

Label Updates

Since this new indication extends the use of FORTEO to patients with GIO who may be younger than those currently receiving the medication, Lilly has updated the language in the existing boxed warning section of the label regarding the risk of osteosarcoma to reinforce that FORTEO should not be used in pediatric and young adult patients whose bones are still growing.

In addition, due to the increased patient population, Lilly established a voluntary FORTEO Patient Registry to further evaluate the long-term safety of FORTEO. Osteosarcoma is a serious but rare cancer which occurs at a rate of about four cases per million people, per year. Osteosarcoma has been reported rarely in people who took FORTEO. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma.

About FORTEO

FORTEO is also indicated for the treatment of osteoporosis in postmenopausal women who are at high risk for fracture and to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture.(6) FORTEO is the first osteoporosis therapy approved by the U.S. Food and Drug Administration (FDA) that actually rebuilds bone.(7) Since receiving FDA approval in November 2002, more than 3.1 million prescriptions for FORTEO have been
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SOURCE Eli Lilly and Company
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