Worrying heart signal may impact hopes for early approval of osteoporosis drug
Belgian drugmaker UCB (Euronext: UCB) and US biotech Amgen (Nasdaq: AMGN) have announced strong efficacy data from their Evenity (romosozumab) study, but a worrying safety signal caused shares in UCB to fall more than 10%.
The trial into Evenity, which is under co-development as a therapy for postmenopausal women with osteoporosis, met both primary endpoints and the key secondary endpoint.
However, a new safety signal was observed - a greater number of serious adverse events for the test group, 2.5% for romosozumab versus 1.9% for alendronate, at 12 months.
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