BRIEF—EMA accepts Evenity filing

Belgian drugmaker UCB and US biotech Amgen have announced that the European Medicines Agency has accepted the Marketing Authorization Application for Evenity (romosozumab) for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture.

The companies are co-developing Evenity, the approval of which in Europe would create a new osteoporosis treatment that increases bone formation and reduces bone resorption simultaneously to increase bone mineral density and lower the risk of fracture.

Pascale Richetta, head of bone and executive vice president at UCB, said: “We are currently seeing a large gap in the management and treatment of osteoporosis, especially in the post-fracture setting, with an estimated four out of five patients remaining undiagnosed and untreated after a fracture. Without adequate management, some fragility fractures may lead to a loss of autonomy in patients’ daily lives.

“At UCB, we are striving to help patients avoid potentially debilitating fractures and to help close this concerning gap.”