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Amgen And UCB Say FDA Issues CRL For BLA For EVENITY

Amgen (AMGN) and UCB said that the U.S. Food and Drug Administration has issued a Complete Response Letter for the Biologics License Application or BLA for EVENITY or romosozumab as a treatment for postmenopausal women with osteoporosis.

The original 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 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.

"During our interactions with the FDA, we agreed that the ARCH data should be considered in the regulatory review prior to the initial marketing authorization and, as a result, anticipated this request. We look forward to working through the review process with the Agency," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.

by RTT Staff Writer

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