FDA withholds approval, demands full data from Evenity trials
The US Food and Drug Administration has not approved an application from Belgian drugmaker UCB (Euronext: UCB) and US biotech Amgen (Nasdaq: AMGN) to market Evenity (romosozumab) as a treatment for postmenopausal women with osteoporosis.
The American regulator issued a Complete Response Letter notification that data from the Phase III ARCH and BRIDGE studies should be integrated into the application.
The original submission included data from the pivotal FRAME study. At the time of its publication, the results from this study caused shares in the Belgian firm to fall 10%, due to the observation of a cardiovascular safety signal.
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