July 16, 2017 / 10:22 PM / a month ago

BRIEF-Amgen and UCB provide update on regulatory status of Evenity in U.S.

July 16 (Reuters) - Amgen Inc:

* Amgen and UCB provide update on regulatory status of Evenity (Romosozumab) in the US

* Co, UCB announced u.s. FDA has issued a complete response letter for Biologics License Application (BLA) for evenity

* Original submission included data from pivotal phase 3 placebo-controlled frame study of postmenopausal women with osteoporosis

* Amgen - with availability of data from phase 3 active-comparator arch study, agency has asked efficacy data from study be integrated into application

* Amgen inc - resubmission will also include efficacy and safety data from bridge study, phase 3 trial evaluating evenity in men with osteoporosis Source text for Eikon: Further company coverage:

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