Health
Study Sees “Probable” Higher Heart Risk for New Amgen Osteoporosis Drugs
By Vishwadha Chander
(Reuters)-Amgen’s observational study of the new osteoporosis drug Evenity, released Wednesday, increases the risk of serious heart problems detected in clinical trials and included in drug prescribing information. Seems to be confirming.
The drug, chemically known as lomosozumab, received US and European approval in 2019 for postmenopausal women with osteoporosis. Regulators in both the United States and Europe have called for warnings on labels of potential risks of cardiovascular complications such as heart attacks. It is also approved in Japan.
Refinitiv data showed that the drug had sales of $100 million in the first quarter of 2020. Analysts forecast annual revenues of $676 million in 2022, which will exceed $900 million by 2026.
The US list price is $21,900 for a 12-month injection.
Homogeneity reduces the risk of fractures and helps build new bone in people with osteoporosis by blocking a protein called sclerostin that prevents bone formation.
It’s uncertain whether the cardiovascular risk seen in the lomozumab trials is true, Jonas Bobbiin, a research author at the Big Data Institute at Oxford University, told Reuters.
According to a report published in Science Translational Medicine, researchers examined data from nearly 4,300 clinical trials and found that “the risk of cardiovascular events from romosozumab is likely to be high.”
Amgen did not immediately respond to a request for comment.
The researchers also analyzed data from more than one million people in the general population with genes that block sclerostin, mimicking the effects of romosozumab. On average, these people had a 41% lower risk of fractures and an 18% higher risk of heart attack.
The findings suggest that adverse cardiovascular effects are real and support warning labels issued by regulatory agencies, but patients currently on prescription lomozozumab should stop treatment. It doesn’t mean that there is, Bobin said.
Instead, patients and health care providers need to consider whether the benefits of fracture prevention outweigh the potential heart risks, Bobin said.
“We hope our findings will lead to a rigorous assessment of the cardiovascular safety of lomozumab and other sclerostin inhibitors.”
(Report by Vishwadha Chander, Bangalore, edited by Bill Berkrot)
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