Research & Development
Amgen & UCB partnership resubmits EVENITY's BLA with the US FDA for treating osteoporosis in postmenopausal women
16 July 2018 -

Biotechnology company Amgen (NASDAQ:AMGN) and biopharmaceutical UCB (Euronext Brussels:UCB) on Friday jointly reported the resubmission of the Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for EVENITY for treating osteoporosis in postmenopausal women at high risk for fracture.

According to the company, EVENITY (romosozumab), which is an investigational monoclonal antibody, is designed to work by inhibiting the activity of sclerostin, which enables EVENITY to rapidly increase bone formation and reduce bone resorption simultaneously

The company said the original US FDA submission included data from a comprehensive Phase 1 and Phase 2 programme and the Phase 3 placebo-controlled FRAME study, including 7,180 postmenopausal women with osteoporosis.

EVENITY's updated BLA includes results from two more recent pivotal Phase 3 trials: the ARCH study, an alendronate-active comparator trial including 4,093 postmenopausal women with osteoporosis who experienced a fracture as well as the BRIDGE study, including 245 men with osteoporosis. The US FDA will evaluate the clinical risk profile of EVENITY, the cardiovascular and safety signal seen in postmenopausal women with osteoporosis, disclosed the company.

In conjunction, the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Device Agency (PMDA) in Japan are currently reviewing marketing applications for EVENITY and interactions with the agencies are ongoing, concluded the company.



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