Drug Approvals

Amgen wins approval for osteoporosis drug — but with strict warnings

Apr 10, 2019

The FDA has greenlighted Amgen’s new osteoporosis drug for postmenopausal women. But the treatment, Evenity, will come with the agency’s strictest warning — a boxed label restricting women who have had a heart attack or stroke in the previous year from using the medication.  

Amgen had originally developed the drug, a monthly injection, for all menopausal women. But cardiovascular risks emerged in phase 3 trials, forcing the company to narrow its target demographic. 

For those able to take Evenity, the drug boasts additional benefits over conventional treatments. In addition to helping to prevent bone loss, Evenity is designed to boost bone growth by inhibiting a protein that impacts bone formation. 

Analysts have forecasted that peak sales for Evenity could reach $500 million. 

Read the full Reuters report.