CHMP recommends Lilly's Forsteo

US drug major Eli Lilly says that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA) has issued a positive opinion recommending approval of Forsteo (teriparatide [rDNA origin] injection) for the treatment of osteoporosis associated with sustained, systemic glucocorticoid therapy in women and men at increased risk for fracture. The opinion issued by the CHMP will need to be ratified by the European Commission, Lilly stressed.

The agent works to stimulate new bone formation by increasing the number and action of bone-building cells called osteoblasts. Originally authorized for marketing in 2003 for osteoporosis in postmenopausal women at high risk for fracture, teriparatide received an expanded indication for the treatment of men at increased risk for fracture in 2007.

"Research has shown that patients taking chronic glucocorticoid therapy may begin to experience bone loss after three to six months of such treatment, resulting in a high incidence of fractures in this patient population," said Gwen Krivi, vice president of Lilly Research Laboratories. "Today's decision by the CHMP brings us one step closer to providing teriparatide as a treatment option for patients suffering from glucocorticoid-induced osteoporosis," she added.