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FDA: More CV data needed on Tresiba, Ryzodeg before approval
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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.
In November, the FDA Endocrinologic and Metabolic Drugs Advisory Committee recommended that a CV outcomes trial should be completed and voted 8-4 in favor of the approval.
According to the release, Novo Nordisk said they do not plan to provide the CV outcomes trial data this year.
Perspective
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Irl B. Hirsch, MD
The FDA decision is both a disappointment and unexpected, but certainly understandable. It also sets a new bar for insulin as far as safety is concerned. I wonder if insulin glargine (Lantus) would have been approved by today’s FDA with the concern at the time (2000) of that insulin causing diabetic retinopathy. What is clear is that after the recent history of rosiglitazone all diabetes drugs, including insulin, will have a new set of safety expectations we did not see in the past. Overall this is beneficial in today’s world of diabetes (compared to 20 years ago), since we didn’t have the choices of other options like we do now.
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