BioCentury
ARTICLE | Company News

Amgen, UCB again seeking FDA nod for osteoporosis mAb

July 13, 2018 8:22 PM UTC

A year after receiving a complete response letter for Evenity romosozumab, Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) have resubmitted a BLA to FDA for the mAb to treat osteoporosis.

During Evenity's initial FDA review in 2017, the partners revealed a previously unseen cardiovascular safety signal in the Phase III ARCH study. The BLA did not include ARCH's data (see "CV Signal in Osteoporosis Trial Sinks UCB, Amgen Shares")...