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FORSTEO(R) Receives Approval from the European Commission for the Treatment of Glucocorticoid-Induced Osteoporosis
Date:4/4/2008

of medicine at the Leuven University Centre for Metabolic Bone Diseases in Belgium. "This new indication for teriparatide provides physicians and patients with a new treatment option that builds bone."

The submission package to support the safety and efficacy profile of teriparatide included new data from the "Teriparatide or Alendronate in Glucocorticoid-Induced Osteoporosis" study, which was published in the November 15, 2007 issue of the New England Journal of Medicine. This head-to- head comparative study showed that in patients with glucocorticoid-induced osteoporosis, teriparatide significantly increased lumbar spine bone mineral density (BMD) from baseline (7.2 percent) compared to alendronate (3.4 percent) at 18 months of therapy.(3)

Information about Teriparatide

Teriparatide is the active fragment (1-34) of the human parathyroid hormone and acts to stimulate bone formation by directly affecting bone forming cells (osteoblasts), indirectly increasing the intestinal absorption of calcium and increasing the re-absorption of calcium and excretion of phosphate by the kidney. Teriparatide, marketed in the U.S. since 2002, was first approved in the E.U. in 2003 for the treatment of established osteoporosis in postmenopausal women who have an increased risk of fracture.

As part of drug testing, teriparatide was given to rats for a significant part of their lifetime. In these studies, teriparatide caused some rats to develop osteosarcoma, a bone cancer. Osteosarcoma in humans is a serious but very rare cancer. Osteosarcoma occurs in about four out of every million older adults each year. It is not known if humans treated with teriparatide also have a higher chance of getting osteosarcoma.

Teriparatide should be prescribed only to patients for whom the potential benefits are considered to outweigh the potential risk. The drug should not be prescribed for patients at increased baseline risk for osteosarcoma, including patients with
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SOURCE Eli Lilly and Company
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