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ARCH CV Signal Scuppers Blockbuster Hopes For Amgen/UCB's Evenity

 
• By Alexandra Shimmings

New Phase III data for the novel osteoporosis therapy romosozumab are set to delay its approval, reduce its commercial potential and open the market to rivals.

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Crumbling ARCH: Data Reduce Likelhood Of Approval • Source: Shutterstock

A cardiovascular safety signal has overshadowed positive efficacy data for Amgen Inc./UCB SA's first-in-class osteoporosis therapy Evenity (romosozumab) in the 4,000-patient Phase III ARCH study, and is expected to push back its US approval by at least a year and reduce its blockbuster potential.

The setback follows the failure of Merck & Co. Inc.'s odanacatib last year on a stroke risk and leaves...

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