Complete Response Letter from FDA for Evenity (romosozumab) as a treatment for postmenopausal women with osteoporosis. - Amgen +UCB.

Amgen and UCB announced that the FDA has issued a Complete Response Letter for the Biologics License Application (BLA) for Evenity (romosozumab) as a treatment for postmenopausal women with osteoporosis. The original submission included data from the pivotal Phase III placebo-controlled FRAME study of postmenopausal women with osteoporosis. With the availability of data from the Phase III active-comparator ARCH study, the FDA 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 III 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.

Comment: The Phase III ARCH trial,showed a high rate of cardiovascular serious adverse events in the Evenity group compared with the Forteo (teriparatide) comparator group. The resubmission also must include data from the third pivotal study, BRIDGE, in men with osteoporosis.