Amgen Inc. AMGN and Belgian partner UCB announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a negative opinion on the marketing approval of its osteoporosis drug, Evenity (romosozumab).
Amgen is seeking an approval of Evenity for the treatment of severe osteoporosis in postmenopausal women, who stand at a risk of fracture.
The companies are planning to submit a written notice to the regulatory agency, requesting a re-evaluation of Evenity for the given indication.
Notably, Evenity gained an approval in the United States earlier this April for the treatment of osteoporosis in postmenopausal women, who are at high 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 that it should not be administered to patients, who already suffered 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.
The drug had received an approval for a similar indication in postmenopausal women as well as men in Japan, earlier this January.
This CHMP’s response was based on data from three pivotal phase III studies, namely FRAME, ARCH and BRIDGE, which evaluated Evenity in postmenopausal women with osteoporosis, who are at a high risk of fracture and men with osteoporosis.
Evenity treats osteoporosis by increasing bone formation and reducing bone resorption simultaneously. This increases bone mineral density (BMD) and lowers the risk of fracture.
Shares of Amgen have decreased 5.5% so far this year versus the industry’s increase of 2.7%.
We remind investors that Evenity was issued a complete response letter (CRL) by the FDA in July 2017 due to a cardiovascular side effect observed in a study. Last July, Amgen and UCB re-submitted the biologics license application (BLA) to the regulatory body for Evenity.
Notably, Evenity is likely to face stiff competition from Radius Health’s RDUS Tymlos injection, which is already approved for treating postmenopausal women with osteoporosis, who are at a high risk of fracture. Novartis’ NVS Reclast is also approved for treating osteoporosis.
Zacks Rank & Key Pick
Amgen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Acorda Therapeutics, Inc. ACOR, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Acorda’s loss per share estimates have been narrowed 6.5% for 2019 and 6.9% for 2020 over the past 60 days.
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