Amgen and UCB report positive efficacy data for Evenity in osteoporosis

Amgen and UCB have reported new clinical trial data that highlights the efficacy of their new osteoporosis therapy Evenity.

Data from the ARCH study met both primary endpoints and the key secondary endpoint, with treatment with Evenity for 12 months followed by alendronate shown to significantly reduce the incidence of new vertebral and clinical fractures over 24 months in postmenopausal women with osteoporosis at high risk for fracture.

The risk of nonvertebral fractures was also reduced compared to alendronate alone, though an imbalance in positively adjudicated cardiovascular serious adverse events was also observed and recorded as a new safety signal.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "Together with UCB, we will engage with global regulators and medical experts in the field to conduct a thorough evaluation of this data."

Regulatory submissions for Evinity based on the results from the previous FRAME study are currently under review in the US, Canada and Japan, with ARCH data now set to be taken into consideration. The preparation for the European regulatory submission will continue as planned.

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