EU Rejects Amgen’s EVENITY

negative opinion on EVENITY

The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced it has adopted a negative opinion on EVENITY (romosozumab-aqqb), an osteoporosis drug for postmenopausal women with high fracture risk.

The U.S. FDA approved the Amgen drug in partnership with UCB in April, but the approval came with a boxed warning for possible increased risk of heart attack, stroke, and cardiovascular death. The FDA also stated, “Health care professionals should also consider whether the benefits of Evenity outweigh its risks in those with other risk factors for heart disease and should discontinue Evenity in any patient who experiences a heart attack or stroke during treatment.”