Amgen, Inc. (NASDAQ:AMGN) and UCB have revealed that the Food and Drug Administration (FDA) has sent a response letter for the biologics license application (BLA) for EVENITY.
EVENITY, also known as romosozumab is a treatment for postmenopausal women with osteoporosis. Amgen and UCB originally submitted the application including data from the placebo-controlled Phase 3 FRAME study of osteoporosis treatment in postmenopausal women. The FDA was provided with data from the Phase 3 active-comparator ARCH study but it has also requested for toe safety and efficacy data recorded in the study to be provided as part of the application. The requested resubmission is also expected to include the safety and efficacy data from the BRIDGE study as well as from the Phase 3 trials for the treatment in men suffering from the disease.
“During our interactions with the FDA, we agreed that the ARCH data should be considered in the regulatory review prior to the initial marketing authorization and, as a result, anticipated this request. We look forward to working through the review process with the Agency,” stated Sean E. Harper, M.D., the executive VP of research and development at Amgen.
Amgen, UCB Dedicated To Further Osteoporosis Research
Harper also pointed out that his firm would maintain its commitment towards helping osteoporosis patients. He also pointed out that Amgen plans to invest more time towards understanding the risk and benefit profile of EVENITY. UCB Vice President Dr. Pascale Richetta stated that a woman with a fragility fracture has five times more likely to suffer another one within 12 months. This is reason enough for more efforts towards reducing the risks of disabling and painful fractures in the future as well as improving post-fracture care.
Dr. Richetta also pointed out that the three Phase 3 clinical trials of the treatment have collected data from more than 11.000 patients. This represents the commitment that Amgen and UCB have towards coming up with new treatment for those at risk of fragility fractures. The two remain highly committed to the cause and are very optimistic about the future of EVENITY.
Amgen stock closed the latest trading session on Friday at $117.13.