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FDA Panel Supports Approval of Novo’s Long-Acting Insulin Despite Heart Concerns

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FDA advisers voted 8–4 Thursday in support of approval for Novo Nordisk’s ultra-long acting insulin candidates Tresiba and Ryzodeg for Type 1 and Type 2 diabetes despite lingering worries about cardiovascular effects. The Endocrinologic and Metabolic Drugs Advisory Committee also voted unanimously in favor of requiring a cardiovascular outcomes trial with Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart). Panelists split on whether the trial should be conducted in the pre- or postmarket setting.
Drug Industry Daily