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Amgen's Osteoporosis Drug Evenity Gets Approval in Europe

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Amgen Inc. (AMGN - Free Report) 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 (RDUS - Free Report) Tymlos injection, which is already approved for treating postmenopausal women with osteoporosis, who are at a high risk of fracture.

 

Zacks Rank & Key Picks

Amgen currently carries a Zacks Rank #3 (Hold). 

A few better-ranked stocks in the biotech sector are Alkermes Plc. (ALKS - Free Report) , and Anika Therapeutics Inc. (ANIK - Free Report) , both  sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ earnings per share estimates have increased from 36 cents to 52 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 236.80%, on average.  

Anika’s earnings per share estimates have increased from $1.75 to $2.03 for 2019 and from $1.38 to $1.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 53.31%, on average.

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