Amgen and UCB announced that the companies have been informed the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application for EVENITYTM (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, 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; ARCH, including 4,093 postmenopausal women with osteoporosis at high risk for fracture; and BRIDGE, including 245 men with osteoporosis.
“We are disappointed with the CHMP opinion and believe that the body of evidence submitted supports a positive benefit:risk profile for EVENITY and its use in helping address the urgent need to improve post-fracture care and reduce the risk of painful, disabling fractures in postmenopausal women with severe osteoporosis at high risk of fracture,”
said Dr. Pascale Richetta, head of bone and executive vice president, UCB.
“Together with Amgen we will seek a re-examination of the CHMP opinion. The re-examination process gives us the opportunity to clarify our position on the submitted data with the goal of making EVENITY available to postmenopausal women at high risk of fracture in the EU.”
EVENITY (romosozumab-aqqg) was approved by the U.S. Food and Drug Administration (FDA) in April 2019, for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY is also approved in Japan and South Korea for the treatment of osteoporosis for women and men at high risk for fracture and in Canada for the treatment of osteoporosis for postmenopausal women at high risk for fracture.