Evenity re-filed (BLA) with FDA for osteoporosis.- Amgen + UCB.

Amgen and UCB announced the resubmission of the Biologics License Application (BLA) to the FDA for Evenity (romosozumab), a monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Evenity increases bone formation and reduces bone resorption simultaneously to increase bone mineral density (BMD) and reduce the risk of fracture. The BLA for Evenity now adds results from two more recent pivotal Phase III trials: the ARCH study, an alendronate-active comparator trial including 4,093 postmenopausal women with osteoporosis who experienced a fracture, and the BRIDGE study, including 245 men with osteoporosis.

The FDA will evaluate the clinical benefit:risk profile of Evenity, including the cardiovascular safety signal seen in the ARCH study, for the potential to reduce the risk of fractures and increase BMD in postmenopausal women with osteoporosis. The original FDA submission included data from a comprehensive Phase I and Phase II program and the Phase III placebo-controlled FRAME study, including 7,180 postmenopausal women with osteoporosis.

Comment: originally filed with the FDA in 2016, the FDA provided a complete response letter the following year asking that the efficacy and safety data from the ARCH study be integrated into the application. The ARCH trial showed a high rate of cardiovascular serious adverse events in the Evenity group compared with the Forteo (teriparatide) comparator group. The FDA also asked that the resubmission also include data from the third pivotal study, BRIDGE, in men with osteoporosis. The European Medicines Agency and the Pharmaceuticals and Medical Device Agency in Japan are currently reviewing marketing applications for Evenity.