An observational study of Amgen Inc's new osteoporosis drug Evenity released on Wednesday appears to confirm the increased risk of serious heart problems detected in clinical trials and included in the medicine's prescribing information.
The drug, chemically known as romosozumab, won U.S. and European approval in 2019 for postmenopausal women with osteoporosis. Both U.S. and European regulators required a warning in the label of the potential risk of cardiovascular complications, such as heart attacks. It is also approved in Japan.
The drug had sales of $100 million in the first quarter of 2020. Analysts forecast annual sales of $676 million in 2022 and exceeding $900 million by 2026, according to Refinitiv data.
Its has a U.S. list price of $21,900 for 12-months of injections.
Evenity reduces fracture risk and helps build new bone in people with osteoporosis by blocking a protein called sclerostin that interferes with bone formation.
There has been uncertainty if the cardiovascular risks seen in romosozumab clinical trials were real, study author Jonas Bovijn from the University of Oxford's Big Data Institute told Reuters.
The researchers looked at clinical trial data of nearly 4,300 people and found "a probable higher risk of cardiovascular events with romosozumab," according to the report published in Science Translational Medicine.
Amgen did not immediately respond to requests for comment.
The researchers also analyzed data on more than a million people in the general population with genes that block sclerostin, mimicking the effect of romosozumab. On average, these people had a 41% lower risk of fracture, but an 18% higher risk of heart attack.
The findings suggest the adverse cardiovascular effects are real and support the warning labels issued by regulatory authorities, but does not mean patients currently prescribed romosozumab should stop treatment, Bovijn said.
Instead, patients and healthcare providers should consider if the benefits of fracture prevention outweigh the potential heart risk, Bovijn said.
"We hope our findings will lead to rigorous evaluations of the cardiovascular safety of romosozumab and other sclerostin inhibitors."
(Reporting by Vishwadha Chander in Bengaluru; editing by Bill Berkrot)
