28 June 2019 - Amgen and UCB today announced that the companies have been informed the CHMP of the EMA has adopted a negative opinion on the Marketing Authorization Application for Evenity (romosozumab) for the treatment of severe osteoporosis. The companies intend to submit a written notice for a re-examination by the CHMP.

"After a fracture, postmenopausal women with osteoporosis are five times more likely to fracture in the subsequent year,1 and these fractures can be life-changing. Yet these patients often remain undiagnosed and untreated and could benefit from a new treatment option with 12 monthly doses to reduce their risk of a fracture," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are disappointed by the Committee's opinion and continue to believe that Evenity has a positive benefit:risk profile. Amgen and UCB remain committed to working with regulatory authorities around the world to bring Evenity to patients and physicians who need additional treatment options for osteoporosis."

The opinion is based on results from a large development program including three pivotal Phase 3 studies comprised of nearly 12,000 patients: FRAME, including 7,180 postmenopausal women with osteoporosis at risk for fracture;2 ARCH, including 4,093 postmenopausal women with osteoporosis at high risk for fracture;3 and BRIDGE, including 245 men with osteoporosis.

Read Amgen press release