FDA approves new drug indication for Forteo

On July 23, Eli Lilly and Company announced that the Food and Drug Administration (FDA) has approved a new use for its osteoporosis drug Forteo (teriparatide) 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, according to a statement from Eli Lilly.

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.

Approximately 50 percent of individuals who are prescribed chronic glucocorticoid therapy will eventually have an osteoporotic fracture. The use of glucocorticoid medications can lead to a reduction in bone formation, the company said. Forteo has been shown to counter this effect by stimulating bone formation.

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 baseline 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.

“Until now, physicians and patients had only one class of approved therapy for the treatment of glucocorticoid-induced osteoporosis,” said Kenneth G. Saag, MD, 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.”