Amgen, Inc. AMGN and its partner UCB announced that the FDA has approved Evenity (romosozumab-aqqg) for treating osteoporosis in postmenopausal women at high risk of fracture.
Evenity is the first and only approved drug for osteoporosis to increase bone mineral density (“BMD”) and reduce the risk of fracture. The drug had received approval for a similar indication in postmenopausal women as well as men in Japan in January. A regulatory application is under review in Europe.
We remind investors that a regulatory application seeking approval for Evenity in the United States was issued a complete response letter by the FDA in 2017 due to a cardiovascular side effect observed in a study.
Please note that the current approval for Evenity by the FDA comes with a boxed warning. The drug’s label states that treatment with Evenity may increase risk of myocardial infarction (heart attack), stroke and cardiovascular death and that it should not be administered to patients who have suffered heart attack or stroke in the preceding year. The company is also required to conduct a post-marketing study to evaluate the cardiovascular safety of Evenity in postmenopausal osteoporosis women.
Shares of the company have declined 0.9% so far this year against the industry’s increase of 11.4% in that period.
The approval for Evenity in the United States is backed by data from two late-stage clinical studies – FRAME and ARCH.
Data from the FRAME study demonstrated that treatment with the drug led to significant reduction in new vertebral (spine) fracture compared to placebo at 12 months. A follow-up treatment with Amgen’s another osteoporosis drug Prolia (denosumab) maintained the reduction in fracture risk over the next 12 months. Moreover, treatment with Evenity in the first year and a follow-up treatment with Prolia showed increase in bone mineral density (“BMD”).
The ARCH study data showed that treatment with Evenity in the first year and a follow-up treatment with Merck’s MRK Fosamax (alendronate) resulted in statistically significant reduction in new vertebral fracture in patients. A similar treatment regimen in the first 24 months showed significantly increased BMD compared to a regimen consisting of Fosamax alone.
Per the press release, there are approximately 10 million people suffering from osteoporosis in the United States, which leads to two million fractures every year. More than 600,000 patients require hospital or nursing home admission for osteoporosis-related fractures annually. The osteoporosis market is expected to reach $25.3 billion by 2025. These factors represent a good opportunity for Evenity in the country and the dual nature of efficacy (increase in BMD and reduction in fracture risk) may boost demand for the drug.
Radius Health’s RDUS Tymlos injection, which received approval for treating postmenopausal women with osteoporosis at a high risk of fracture in 2017, had a strong 2018 with sales growing sequentially in every quarter to reach almost $100 million. Evenity is likely to face competition from Tymlos. There are several other approved drugs for osteoporosis including Novartis’ NVS Reclast.
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Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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