Amgen and UCB’s Evenity accepted for EU regulatory review

Amgen and UCB have announced that their osteoporosis drug Evenity has been accepted for review by European regulators.

The European Medicines Agency has accepted the marketing authorisation application for Evenity, which will now be assessed for the treatment of osteoporosis in postmenopausal women and men at increased risk of fracture.

If approved, the drug will serve as a novel treatment that increases bone formation and reduces bone resorption simultaneously, thereby improving bone mineral density and reducing the risk of fracture.

This application is supported by evidence from three pivotal phase III studies, which between them offer data from more than 11,000 patients, and have demonstrated that Evenity can reduce the risk of fractures and offer strong cardiovascular safety.

Dr Sean Harper, executive vice-president of research and development at Amgen, said: "Amgen has a legacy of addressing the needs of patients with osteoporosis, and Evenity has the potential to deliver fracture risk reduction to patients."

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