Type of information: Submission of a Market Application in the EU
Product name: Evenity®
Therapeutic area: Bone diseases
- monoclonal antibody. Romosozumab (CDP7851/AMG 785) is a humanized monoclonal antibody that binds to and inhibits sclerostin, a protein secreted by bone cells that inhibits bone formation. By binding to and blocking sclerostin, it is designed to increase the amount of bone in the skeleton. With more than 75 million people worldwide suffering from osteoporosis, there is a serious patient need for therapeutics that help build bone.
Company: Amgen (USA - CA) UCB (Belgium)
- osteoporosis in postmenopausal women and men at increased risk of fracture
- • On January 8, 2018, Amgen and UCB announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for Evenity® (romosozumab) for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture. If approved in Europe , Evenity® will be a novel osteoporosis treatment that increases bone formation and reduces bone resorption simultaneously to increase bone mineral density (BMD) and reduce the risk of fracture.
- The MAA for Evenity® is based on results from three pivotal Phase 3 studies: FRAME, including 7,180 postmenopausal women with osteoporosis; ARCH, including 4,093 postmenopausal women with osteoporosis at high risk for fracture; and BRIDGE, including 245 men with osteoporosis. The agency will evaluate the clinical benefit:risk profile of Evenity® in these three pivotal studies, including the potential to increase BMD and reduce the risk of fractures in women with osteoporosis, as well as the cardiovascular safety signal seen in the ARCH study.
- • On July 17, 2017, UCB and Amgen 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 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 romosozumab 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.
- • On July 22, 2016, Amgen and UCB announced the submission of a Biologics License Application (BLA) to the FDA for romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
The BLA for romosozumab is based on data from the pivotal Phase 3 FRAME study in approximately 7,200 patients.
Submission of marketing authorization application USA : 2016-07-22
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: