Merck & Co has revealed positive results from a phase III fracture outcomes study for odanacatib in postmenopausal women with osteoporosis.
The company had intended to file the drug for approval in 2013 but put that plan on hold while it looked into a ‘safety signal’ of odanacatib.
Dr Keith Kaufman, vice president of clinical research for diabetes and endocrinology, said: “Merck believes the currently available data support a favourable benefit/risk profile for odanacatib.”
Among the adverse events checked during the trial were atrial fibrillation and major adverse cardiovascular events (MACE). Atrial fibrillation was reported in 92 patients in the odanacatib group and 80 patients in the placebo group; MACE were reported for 215 patients in the odanacatib group and 194 patients in the placebo group.
Merck said it would continue to collect data from the study and plans additional analyses of data from the trial including an independent re-adjudication of major adverse cardiovascular events, in support of regulatory submissions.
The study enrolled 16,713 women aged 65 years of age or older, diagnosed with osteoporosis, who have been postmenopausal for five years of more. Patients were randomised to receive 50mg of odanacatib or placebo per week.
In the long-term odanacatib fracture trial (LOFT), the cathespin inhibitor met its primary endpoints – significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with a placebo.
Compared to patients receiving placebo, patients who received odanacatib had 72% relative risk reduction of clinical vertebral fractures and 54% relative risk reduction of new or worsening morphometric vertebral fractures.
The trial also found 47% relative risk reduction of clinical hip fractures and 23% relative risk reduction of clinical non-vertebral fractures.
Treatment with odanacatib also led to progressive increases in bone mineral density (BMD) over five years at the lumbar spine and total hip. Compared to the placebo, the change in BMD for lumbar spine was 11.2% and 9.5% for the total hip.