An FDA advisory panel on Wednesday voted 18-1 that the benefits of Amgen and UCB's monthly injection Evenity (romosozumab) outweigh its risks for the treatment of osteoporosis in postmenopausal women at high risk for fracture. Two members of the panel voted in favour of the sclerostin inhibitor, but proposed approving it for a different indication. The committee also raised concerns of potential cardiovascular risks linked to Evenity, which FDA staff reviewers earlier this week had cited as the main reason for convening the advisory panel meeting.
In 2017, the agency issued a complete response letter to the companies regarding their submission of Evenity, asking them to include efficacy and safety data from the Phase III ARCH study in their filing. In the trial, Evenity was associated with a higher rate of serious cardiovascular adverse events than Merck & Co.'s Fosamax (alendronate).
Amgen and UCB resubmitted their filing seeking approval of Evenity to the FDA last July. Still, despite the panel vote backing approval, some panellists again expressed concerns about the drug's cardiovascular risks. "I don't think we've adequately characterised cardiovascular safety," said Pamela Shaw, who voted in favour of approval for Evenity. She added "I don't know the perfect solution, but relying on observational data only post approval, I don't think, will help us answer this reliably. My vote is relying on a high-quality post-marketing study."
For related analysis, see ViewPoints: Evenity's hopes in US just got a boost from unlikely source. See also ViewPoints: Evenity passes somebody's muster.
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