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# Complete Response Letter on Amgen Bone Drug
- URL: https://www.fdaweb.com/complete-response-letter-on-amgen-bone-drug/
- Published: 2017-07-17T12:00:00.000Z
- Updated: 2026-09-14T22:34:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139144

FDA has issued Amgen a Complete Response Letter on its BLA for the Evenity (romosozumab) as a treatment for postmenopausal women with osteoporosis. The initial submission included data from the pivotal Phase 3 placebo-controlled FRAME study of postmenopausal women with osteoporosis. “With the availability of data from the Phase 3 active-comparator ARCH study, the agency has asked that the efficacy and safety data from the study be integrated into the application,” the company says. “The resubmission will also include the efficacy and safety data from the BRIDGE study, the Phase 3 trial evaluating Evenity in men with osteoporosis, which has also been requested. This request will be addressed in the form of a resubmission, which is an extension of the current review.”

Evenity is an investigational bone-forming monoclonal antibody that is designed to work by inhibiting the activity of sclerostin, which enables increased bone formation and reduced bone resorption simultaneously, the company says.

  
The therapy is part of an Amgen and UCB collaboration and license agreement to research, develop and market antibody products targeting the protein sclerostin.