Limited Evenity expectations after long-awaited approval

If Amgen (Nasdaq: AMGN) and UCB’s (Euronext: UCB) expectations for big sales for their partnered asset Evenity (romosozumab) in postmenopausal osteoporis had long since faded, then Tuesday’s approval will likely have further dampened their optimism.

Amgen closed 1% down on Tuesday and UCB was 2% lower as Wednesday’s trading neared its end after the US Food and Drug Administration (FDA) put a safety warning on the drug in announcing its approval, more than two years after the companies first sought FDA authorization.

SVB Leerink analyst Geoffrey Porges explained: “Evenity’s label reflects a Black Box Warning for cardiovascular events and outlines the drug’s lack of proven benefit in reducing non-vertebral fractures compared to placebo, both of which are likely to contribute to the drug’s probable relegation to late-line therapy.”