Eli Lilly and Co (INDIANAPOLIS, Indiana) announced that the European Commission has approved a new indication for Forsteo^® (teriparatide [rDNA origin] injection) for the treatment of sustained, systemic glucocorticoid-induced osteoporosis (GIOP) in adults at increased risk for fracture. The approval follows the initial positive opinion issued in February by the Committee for Medicinal Products for Human Use of the European Medicines Evaluation Agency.

Teriparatide stimulates new bone formation by increasing the number and action of osteoblasts, indirectly increasing the intestinal absorption of calcium and increasing the reabsorption of calcium and the excretion of phosphate by the kidney. Teriparatide, marketed in the US since 2002, was first approved in the EU in 2003 for the treatment of established osteoporosis in postmenopausal women who have an increased risk of fracture. In 2007, the agent received an expanded indication for the treatment of osteoporosis in men at increased risk for fracture.

GIOP is bone loss associated with chronic use of glucocorticoid medications, often prescribed for inflammatory conditions such as rheumatoid arthritis and obstructive pulmonary disease. According to the company, chronic glucocorticoid therapy is the most common cause of secondary osteoporosis, and it has been estimated that 1% to 3% of adults globally >50 years use glucocorticoids.

The submission package to support the safety and efficacy profile of the agent included new data from the "Teriparatide or Alendronate in Glucocorticoid-Induced Osteoporosis" study. That head-to-head comparative study showed that in patients with GIOP, teriparatide significantly increased lumbar spine bone mineral density from baseline (7.2%) compared with alendronate (3.4%) 18 months.

Teriparatide, rhPTH(1-34), is produced in E. coli, using recombinant DNA technology, and is identical to the 34 N-terminal amino acid sequence of endogenous human parathyroid hormone (hPTH).

Teriparatide should not be prescribed for patients at increased baseline risk for osteosarcoma, including patients with Paget's disease of bone or unexplained elevations of alkaline phosphatase, children or growing adults, or those who have had prior external beam or implant radiation therapy involving the skeleton. Additionally, patients with bone metastases or a history of skeletal malignancies, and those with metabolic bone diseases other than osteoporosis, should not receive the agent. Patients with high levels of calcium in their blood should not receive the agent due to the possibility of increasing their blood levels of calcium.

In clinical trials, the most frequent treatment-related adverse events reported at the 20 mg dose approved for marketing were similar to placebo and included nausea, limb pain, headache, and dizziness.

The agent is supplied as once-daily self-administered injections via a disposable pen device that can be used for up to 28 days. Continued use should not exceed 18 months.