Amgen/UCB osteoporosis therapy gets CRL

Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) said FDA issued a complete response letter for Evenity romosozumab to treat osteoporosis in postmenopausal women.

Amgen said in May that it no longer expected FDA to approve Evenity this year, after data from the Phase III ARCH trial revealed a previously unseen cardiovascular safety signal. Evenity is a humanized mAb against sclerostin (see BioCentury Extra, May 22)...