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Heart Safety Clouds Hopes for Amgen, UCB Bone Drug Approval

Bill Berkrot & Ben Hirschler  |  

The medicine met the primary and key secondary goals of a late-stage study. The imbalance in heart-related side effects had not been observed in an earlier Phase III study that had been the basis of the regulatory submission seeking approvals.

In the new trial, romosozumab significantly reduced the incidence of new vertebral fractures through 24 months as well as non-vertebral fractures in postmenopausal women with osteoporosis at high risk for fracture compared with Merck & Co’s Fosomax.

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Serious heart problems were reported, however, in 2.5% of patients who received the Amgen drug, versus 1.9% in the Fosomax group.

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