Posted by Michael Wonder on 17 Jul 2017
Amgen and UCB provide update on regulatory status of Evenity (romosozumab) in the US
16 July 2017 - Amgen and UCB today announced that the U.S. FDA has issued a complete response letter for the biologics license application for Evenity (romosozumab) as a treatment for post-menopausal women with osteoporosis.
The original submission included data from the pivotal Phase 3 placebo-controlled FRAME study of post-menopausal 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 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.
