An experimental osteoporosis drug being developed by Amgen and UCB produced surprising safety data in a phase 3 comparison study.
The companies reported that patients taking the experimental treatment romosozumab (brand name Evenity, if approved) experienced a higher rate of serious cardiovascular-related side effects versus alendronate (Merck & Co’s Fosomax).
Investigators found that 2.5 percent of patients taking romosozumab suffered a cardiovascular-related issue whereas 1.9 percent did in the alendronate group.
However, the drug still met both primary endpoints and a key secondary endpoint, according to the announcement.
The randomized trial was designed to test romosozumab’s efficacy against the rival treatment from Merck on 4,093 postmenopausal women with osteoporosis at high risk of fracture.
The treatment was either administered as 210 mg subcutaneous injection every month over 12 months followed by a 70 mg oral dosage of alendronate every week compared to patients just receiving alendronate.
Results indicated romosozumab was able to achieve both primary endpoints by significantly reducing the incidence of new vertebral fractures and clinical fractures after the 12 months of treatment followed by Merck’s product. The secondary endpoint showed romosozumab could lower the risk of non-vertebral fractures better than Merck’s.
“The efficacy results from this study comparing Evenity to an active control are robust. At the same time, the newly observed cardiovascular safety signal will have to be assessed as part of the overall benefit:risk profile for Evenity,” said Dr. Sean Harper, the executive vice president of Research and Development at Amgen, in a statement. “Together with UCB, we will engage with global regulators and medical experts in the field to conduct a thorough evaluation of these data.”
The announcement released by the companies didn’t specify which cardiovascular-related side-effects occurred during the experiment or the severity.
Amgen’s stock was down 1.6 percent in morning trading while Brussels, Belgium-based UCB’s shares sank over 17 percent on the European market.
Filed Under: Drug Discovery
