Odanacatib significantly reduces osteoporotic fracture risk
Odanacatib is an investigational cathepsin K inhibitor to be taken once in a week.
The company is planning to submit the New Drug Application (NDA) for odanacatib to the US regulatory body FDA by 2015.
In the Long-term Odanacatib Fracture Trial (LOFT), odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine, and non-vertebral fractures as compared to a placebo. The rates of overall adverse events in LOFT were generally balanced between patients taking odanacatib and placebo. In the study, odanacatib significantly reduced osteoporotic fracture risk.
"The effects of odanacatib on fracture risk from the LOFT study are very encouraging," said Mr Michael McClung, LOFT leader and founding director of the Oregon Osteoporosis Center in a statement.
Dr Keith Kaufman, vice president, clinical research, diabetes and endocrinology, Merck said, "Merck believes the currently available data support a favorable benefit/risk profile for odanacatib. We want to thank our investigators who conducted the study and the thousands of patients who participated in this study, which is yielding critical insights into the potential of odanacatib in the treatment of postmenopausal osteoporosis."
The results of the trial were presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Houston, Texas.