Amgen Says FDA Accepts Bone Loss Drug Application
Thu, 02/19/2009 - 4:17am
THOUSAND OAKS, Calif. (AP) — Amgen Inc. said Wednesday the Food and Drug Administration accepted its application for the bone loss drug candidate denosumab, and the company expects the agency to make a ruling by Oct. 19. Amgen asked the FDA to approve the drug in December in a Biologics License Application. Regulators did not accept the application until Wednesday, but they intend to make their ruling 10 months from the date of the submission. The biotechnology company wants the FDA to approve denosumab as a treatment for postmenopausal osteoporosis, and for the prevention of bone loss in patients being treated for prostate cancer or breast cancer. Amgen is also seeking marketing approval in the European Union, Canada, Switzerland and Australia. Analysts see denosumab as a critical piece of Amgen's pipeline and future revenue.