FDA staff largely unfazed by CV signal in Amgen osteoporosis drug trials
FDA staff braved the snow and the federal shutdown to post their review of Amgen’s once-rejected osteoporosis drug on Monday, underscoring that the efficacy of the drug in postmenopausal women had been established, and suggesting that the CV signal observed in two trials may not be a significant worry.
The review comes days after Amgen and partner UCB secured Japanese approval for the drug, romosozumab, and precedes a meeting of independent experts on Wednesday who will make their recommendation on the approvability of the drug in the United States. Romosozumab — which is to be sold under the brand name Evenity — functions predominantly as a bone anabolic agent that stimulates bone growth.
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