Amgen, in collaboration with UCB, has announced the resubmission of the biologics license application (BLA) for their osteoporosis drug candidate, EVENITY (romosozumab), to the US Food and Drug Administration (FDA). This resubmission is targeted at the treatment of osteoporosis in postmenopausal women who are at high risk of fractures, marking a significant development in the management of bone health.

EVENITY, a bone-forming monoclonal antibody, has been designed to dualistically increase bone formation and decrease bone resorption. This dual action not only improves bone mineral density (BMD) but also significantly reduces the risk of fractures in patients. The drug represents a new class of osteoporosis treatment that could substantially alter the standard care for those suffering from severe bone density issues.

Sean E. Harper, Executive Vice President of Research and Development at Amgen, emphasized the drug’s impact, stating, “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. We look forward 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 BLA for EVENITY now includes results from two additional pivotal Phase 3 trials — the ARCH study and the BRIDGE study. The ARCH trial, which is an alendronate-active comparator study, involved 4,093 postmenopausal women with osteoporosis who had previously suffered fractures. The BRIDGE study focused on 245 men with osteoporosis, broadening the scope of EVENITY’s potential impact.

The FDA’s review of EVENITY will carefully assess the clinical benefit-risk profile, including a detailed analysis of the cardiovascular safety signal noted in the ARCH trial. This comprehensive evaluation will determine the drug’s efficacy in reducing fractures and improving BMD in the target population.

Pascale Richetta, Head of Bone and Executive Vice President at UCB, highlighted the broader implications of this development: “The burden of osteoporosis can have a tremendous impact on a patient’s life. We are one step closer in our ability to bring this first-of-its-kind treatment to thousands of women affected by fragility fractures each year.”

In addition to the FDA review, EVENITY is currently under examination by the European Medicines Agency (EMA) in Europe and the Pharmaceuticals and Medical Device Agency (PMDA) in Japan, reflecting its international potential and significance.

EVENITY’s innovative approach could revolutionize treatment options for osteoporosis, particularly for postmenopausal women at high risk of fractures. By offering a treatment that acts on both bone formation and resorption, EVENITY could fill a critical gap in current osteoporosis treatments, which often focus solely on slowing bone loss.

  Amgen, bone health, EVENITY, FDA approval, fracture risk reduction, Osteoporosis, osteoporosis treatment, Pascale Richetta, postmenopausal women, romosozumab, Sean E. Harper, UCB, US FDA, USA