BioCentury
ARTICLE | Clinical News

Amgen/UCB osteoporosis therapy gets CRL

July 21, 2017 6:46 PM UTC

Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) said FDA issued a complete response letter for Evenity romosozumab (CDP7851, AMG 785) 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 (see BioCentury, May 29)...

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