Amgen, UCB resubmit BLA of EVENITY osteoporosis drug to FDA
Amgen and UCB have resubmitted the biologics license application (BLA) of their investigational osteoporosis drug EVENITY (romosozumab) to the US Food and Drug Administration (FDA) for treatment of osteoporosis in postmenopausal women at high risk for fracture.
A bone-forming monoclonal antibody, EVENITY is said to increase bone formation and simultaneously decrease bone resorption, in order to improve mineral density (BMD) while cutting down the risk of fracture.
Commenting on the BLA resubmission of the osteoporosis drug EVENITY, Sean E. Harper – executive vice president of Research and Development at Amgen, said: “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.”
Amgen revealed that the new EVENITY’s BLA also includes findings from two additional pivotal phase 3 trials held recently – the ARCH study and the BRIDGE study. The ARCH trial is an alendronate-active comparator study in 4,093 postmenopausal women with osteoporosis who had a fracture, while the BRIDGE trial featured 245 men with osteoporosis.
Amgen, UCB resubmit BLA of EVENITY osteoporosis drug to FDA. Photo courtesy of Coolcaesar/Wikipedia.org.
The FDA will assess the clinical benefit:risk profile of EVENITY. This will include the cardiovascular safety signal as demonstrated in the ARCH trial, for the potential to bring down the risk of fractures and improve BMD in postmenopausal women with osteoporosis.
The osteoporosis drug’s original FDA submission had data from a Phase 1 and Phase 2 program and the Phase 3 placebo-controlled FRAME trial held in 7,180 postmenopausal women with osteoporosis.
Pascale Richetta – head of bone and executive vice president at UCB, commenting on the BLA resubmission of the osteoporosis drug EVENITY, said: “The burden of osteoporosis can have 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.”
Currently, EVENITY osteoporosis drug is being reviewed in Europe and Japan by the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Device Agency (PMDA), respectively.