The resubmitted biologics license application includes data from pivotal phase 3 studies of more than 11,000 patients.
Amgen and UCB announced the resubmission of the biologics license application to the US Food and Drug Administration (FDA) for romosozumab (EVENITY) for the treatment of osteoporosis in postmenopausal women at high risk for fracture.
Resubmission now includes results from 2 additional recent pivotal phase 2 trials: the ARCH study and the BRIDGE study.
The FDA will evaluate the clinical benefit and risk profile of EVENITY, which includes the cardiovascular safety signal seen in the ARCH study for the potential to reduce the risk of fractures and increase bone mineral density in postmenopausal women with osteoporosis.
“A fracture due to osteoporosis can be a life-altering event, and EVENITY has the potential to reduce fracture risk in patients at high risk due to a prior fracture,” Sean Harper, MD, executive vice president of research and development, Amgen, said in a statement. “We look forwarding to continuing our work with the FDA to demonstrate the benefit risk profile for EVENITY. Our hope is to bring to patients an innovative treatment option that addresses a serious unmet medical need.”
The ARCH study, an alendronate-active comparator trial, includes 4093 postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history. The study evaluated 12 months of 210 mg treatment of EVENITY followed by at least 12 months of 70 mg alendronate treatment, compared with alendronate treatment alone in order to determine effectiveness in reducing the incidence of clinical fracture and new vertebral fracture.
The randomized, double-blind, placebo-controlled BRIDGE study includes 245 men aged 55—90 years old with osteoporosis and a history of fragility fracture or vertebral fracture. The BRIDGE study evaluated the effectiveness of EVENITY treatment for 12 months, compared with placebo, in increasing bone mineral density at the lumbar spine and the effect on the bone mineral density at the femoral neck and total hip.
The investigational monoclonal antibody works to increase bone formation and reduce bone resorption simultaneously, increasing bone mineral density and reducing the risk of fracture.
The original biologics license application included data from a comprehensive phase 1 and phase 2 program and the phase 3 placebo-controlled FRAME study, which included 7180 postmenopausal women with osteoporosis.
The European Medicines Agency and the Pharmaceuticals and Medical Device Agency in Japan are currently reviewing marketing applications for EVENITY.