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Novo Nordisk Won't Be Pursuing Victoza for Type 1 Diabetes

By Kelly Close and Emily Regier

Twitter Summary: In disappointing news, @NovoNordisk will not be submitting Victoza for #T1D to the @US_FDA after results of latest clinical trial

Novo Nordisk announced today in very disappointing news that it would not be submitting its drug Victoza (a GLP-1 agonist) to the FDA for type 1 patients to use. They released the second set of phase 3 results for the second trial required by the FDA, which compared the addition of Victoza to that of a placebo to standard insulin therapy for type 1, and the company's opinion was that the results were not strong enough overall. Whereas type 2 patients had very impressive "composite" results (significantly lower A1c, substantial weight loss, and significantly less hypoglycemia), the composite results for type 1 were not quite as good. The A1c was lower on Victoza than placebo, but not that much lower (~0.5% reductions with Victoza vs. 0.3% with placebo from a baseline of ~8.2%), and the hypoglycemia really wasn't much lower at all. Surprisingly, the biggest effect was on weight, where patients lost nearly ten pounds on Victoza, compared to an average weight gain of about two pounds in people taking placebo.

From our view, these randomized controlled trials are always incredibly hard to interpret – we would have been very happy to see CGM used in this trial or the Abbott FreeStyle Libre, in order to fully assess hypoglycemia. There are so few medications that impact weight positively for type 1 patients, and we are sorry for that reason alone not to see Victoza submitted to the FDA for type 1. That said, it's never been a more challenging time for big pharmaceutical companies in terms of the FDA – as a reminder, insulin degludec (Tresiba) has been delayed by FDA for over three years.

We would be interested in learning more about subgroup analysis – that means which groups of patients did better on Victoza and which groups of patients did worse. None of that information is available yet, and while Novo Nordisk says that it will continue to focus on type 1s in the future, we can imagine it will be some time before there is another new therapy outside of insulin for people with type 1 diabetes to take (though we are very excited to learn more about the use of SGLT-2 inhibitors in type 1 at EASD this year, particularly after Jardiance’s exciting heart safety news in type 2 diabetes last week). We ultimately are still very happy Novo Nordisk invested in this research, and it was certainly a multimillion-dollar decision and a big investment to make. Insurance companies are making increasingly challenging decisions about which medications for both type 1 and type 2 diabetes they will cover (and to what extent), which in turn is making decisions like this very challenging for companies like Novo Nordisk. 

We spoke to Dr. Irl Hirsch at length about his response to this news - Dr. Hirsch is a renowned thinker on GLP-1 and has an active clinic where both type 1s (off label) and type 2s have taken GLP-1. Dr. Hirsch emphasized that he was disappointed by the decision, but not surprised:  "Clinically I can't predict who has a great response, who has a modest response, and who has no response. Put it together in a trial, and the impact is not large enough for a new indication. What would be important is to try to figure out why we see such heterogeneous response rates for glucose and weight. I am hopeful there is enough data available for post-hoc analysis to see what is associated with an improved response.” In talking to Dr. Hirsch about the different patient groups that might respond to GLP-1, he shared, "I remain interested in other populations, the most important being the impact of this drug and GLP-1s in general on beta cell function in newly diagnosed T1D. It also makes me wonder if there were differences in response rate in this study for those type 1's still making significant C-peptide. The other population [outside type 1] to think about is MDI patients with type 2 diabetes."

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