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Application submitted in Japan for romosozumab for osteoporosis treatment
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An application for the approval of romosozumab for the treatment of osteoporosis in adults at high risk for fracture has been submitted to the Pharmaceuticals and Medical Devices Agency in Japan, according to a press release from Amgen and UCB.
The development of romosozumab in Japan is being led by Amgen Astellas BioPharma.
“Submitting romosozumab for marketing approval in Japan is an important milestone in our global development program with UCB and our strategic alliance with Astellas Pharma,” Sean E. Harper, MD, executive vice president of Research and Development at Amgen, said in the release. “We look forward to working with regulatory authorities in Japan with a goal of filling a great unmet need for patients with osteoporosis at high risk of fracture.”
Romosozumab, an investigational monoclonal antibody binds and inhibits sclerostin activity and helps to increase bone formation and decrease bone resorption.
“Our collaborative, patient-led and science-driven approach is bringing much needed treatment options to people living at risk of fracture due to osteoporosis,” Pascale Richetta, MD, head of bone and executive vice president at UCB, said in the release. “We look forward to working with our partners, Amgen and Astellas, as we pursue our goal of bringing this important new treatment to those people living at risk of fracture from osteoporosis worldwide.”