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Amgen, UCB osteoporosis drug Evenity gains 1st approval from Japanese regulator

Amgen Inc. and UCB SA's osteoporosis medicine Evenity received marketing approval from the Japanese Ministry of Health, Labor and Welfare, marking its first regulatory win worldwide.

Osteoporosis causes bones to deteriorate or become brittle and fragile due to low bone mass and bone tissue loss, thus increasing the risk of fractures. The condition is most likely to occur in women after menopause because of the sudden decrease in estrogen, the hormone that normally protects against osteoporosis.

Brussels-based UCB and Amgen have been collaborating to develop antibody products targeting the protein sclerostin as part of a 2004 agreement.

Evenity, or romosozumab, was developed in Japan by Amgen Astellas BioPharma KK, a joint venture between Thousand Oaks, Calif.-based Amgen and Tokyo-based Astellas Pharma Inc., and is approved for osteoporosis patients at high risk of fracture.

The drug is a monoclonal antibody that inhibits sclerostin, enabling it to both increase bone formation and reduce dissolving of the bone.

Evenity's approval in Japan is based on data from two phase 3 studies that showed effectiveness in reducing fractures among men and postmenopausal women with osteoporosis.

The U.S. Food and Drug Administration and the European Medicines Agency are reviewing marketing applications for Evenity.