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FDA: Biologics License Application accepted for romosozumab
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The FDA recently accepted the Biologics License Application for review of romosozumab, according to a press release from Amgen and UCB.
The monoclonal antibody romosozumab may be effective for the treatment of osteoporosis in postmenopausal women.
“We believe romosozumab could serve as an important therapeutic option for osteoporosis patients with an increased risk of fracture,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release. “We look forward to potentially providing a new therapy to address a critical unmet medical need and further supporting patients worldwide.”
The application is based on data from the phase 3 placebo-controlled Fracture Study in postmenopausal women with osteoporosis (FRAME) conducted in nearly 7, 200 patients.
“Once a patient suffers a fragility fracture, the burden of osteoporosis can have a tremendous impact on a patient’s life,” Pascale Richetta, MD, head of bone and executive vice president at UCB, said in the release. “We are pleased with the FDA’s [Biologics License Application] filing for review and hope to continue the regulatory process towards U.S. approval to introduce a potential therapy to reduce the risk of fractures for this patient population.
A Prescription Drug User Fee Act target action date has been set for July 19, 2017.