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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

INDIANAPOLIS, July 23 /PRNewswire-FirstCall/ -- Today, Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has approved a new use for its osteoporosis drug FORTEO((R)) [teriparatide (rDNA origin) injection] to treat osteoporosis associated with sustained, systemic glucocorticoid therapy in men and women at high risk of fracture. Glucocorticoid therapy is the most common cause of secondary osteoporosis, leading to bone loss and an increased risk for fracture.(1)

"Patients who take long-term glucocorticoid therapy are already dealing with a serious health condition, and, on top of that, they may be at a significantly higher risk for fracture," said Vladimir Kopernicky, medical director for Eli Lilly and Company. "The FDA's decision provides these patients with a valuable treatment option for osteoporosis, which they may develop as a result of their sustained glucocorticoid use."

Glucocorticoid-induced osteoporosis, or GIO, is associated with chronic use of glucocorticoid medications, which are often prescribed for inflammatory conditions such as rheumatoid arthritis and obstructive pulmonary disease. Data indicate that glucocorticoid medications are used by up to three out of every 100 adults over age 50. (2) Approximately 50 percent of individuals who are prescribed chronic glucocorticoid therapy will eventually have an osteoporotic fracture.(3) The use of glucocorticoid medications can lead to a reduction in bone formation.(4) FORTEO has been shown to counter this effect by stimulating bone formation.(5)

In the course of the FDA's review of the new indication, Lilly provided data from a clinical study which showed that in patients with glucocorticoid-induced osteoporosis, FORTEO increased bone mineral density (BMD) from baselin
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