Japan approves Amgen’s osteoporosis drug

Amgen’s osteoporosis bone-forming drug Evening (romosozumab) has been approved in Japan, ahead of a crunch review by advisers to the US regulator later this month. Evenity could have been on the US market in 2017, but the FDA rejected it after picking up on an unexpectedly high incidence of cardiovascular events in one of the two phases 3 trials in the company’s first filing. Developed in partnership with Belgium’s UCB, the companies refiled the drug with the FDA last summer with new data from the two trials that they hope will assuage the FDA’s concerns about the drug’s safety.
The Japanese Ministry of Health, Labor and Welfare is the first regulator to approve the drug and will give the companies cause for optimism ahead of the Bone, Reproductive and Urologic Drugs Advisory Committee meeting. Evenity is also under review in Europe, and Amgen hopes the drug will help replace any sales lost to cheaper biosimilars when its big osteoporosis drug, Prolia (denosumab) loses patent protection in the coming years. While the FDA does not always follow the advice of its expert committee, their decisions give a good steer about whether a drug will be approved.