Seeking Cardiovascular Safety Data, FDA Blocks Approval Of Novo Nordisk's Long-Acting Insulin
The FDA informed Novo Nordisk on Friday that it would not approve the company's highly anticipated long-acting insulin degludec products (Tresiba and Ryzodeg) until it receives data from a cardiovascular outcomes trial. Approval of the drugs had been widely anticipated for this year, following a positive recommendation from an FDA advisory committee last fall. But the committee also unanimously recommended that the company be required to perform a cardiovascular outcomes trial.
The FDA informed Novo Nordisk on Friday that it would not approve the company's highly anticipated long-acting insulin degludec products (Tresiba and Ryzodeg) until it receives data from a cardiovascular outcomes trial. Approval of the drugs had been widely anticipated for this year, following a positive recommendation from an FDA advisory committee last fall. But the committee also unanimously recommended that the company be required to perform a cardiovascular outcomes trial.