FDA: More CV data needed on Tresiba, Ryzodeg before approval

The FDA has denied approvals for two potential insulin therapies in the pipeline due to a lack of cardiovascular data, according to a press release. In a letter from the FDA to the manufacturer, the agency wrote that insulin degludec/insulin aspart (Ryzodeg, Novo Nordisk) and insulin degludec (Tresiba, Novo Nordisk) require additional cardiovascular data from an outcomes trial before they will complete the new drug application. The medications are currently approved in the European Union, Japan and Mexico.







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