Amgen's Osteoporosis Drug Evenity Gets Approval In Europe
Zacks Investment Research | Dec 11, 2019 09:36PM ET
Amgen Inc. (NASDAQ:AMGN) and partner UCB announced that the European Commission (EC) has granted marketing authorization to Evenity (romosozumab) for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture.
The approval was supported by the positive opinion given by the Committee for Medicinal Products for Human Use (CHMP) in October 2019. The drug is expected to be launched in Europe in the first half of 2020.
Shares of Amgen have lost 20.2% so far this year against the industry’s growth of 6.7%.
We note that Evenity was approved in April by the FDA. It is the first and only approved drug for osteoporosis to increase bone mineral density (“BMD”) and reduce the risk of fracture. However, the nod came with a boxed warning. The drug’s label states that treatment with Evenity may increase the risk level of myocardial infarction (heart attack), stroke and cardiovascular death and it should not be administered to patients who already suffered a heart attack or stroke in the preceding year. The company is required to conduct a post-marketing study to evaluate the cardiovascular safety of Evenity in postmenopausal osteoporosis women.
In January, the drug received approval for a similar indication in postmenopausal women as well as men in Japan.
Notably, Evenity is likely to face stiff competition from Radius Health’s (NASDAQ:RDUS) Tymlos injection, which is already approved for treating postmenopausal women with osteoporosis, who are at a high risk of fracture.
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