Novo Nordisk walks back some U.S. optimism for its next-gen insulin

Novo Nordisk ($NVO) is sounding a more cautious tone on Tresiba, its once-rejected new insulin. After hinting at an accelerated trip back to the FDA for the long-acting diabetes treatment, the Danish drugmaker now says it could be another few years before the injection is ready for another shot at approval.

Last year, the FDA rejected Tresiba over some troubling safety signals, demanding a costly cardiovascular outcomes study and effectively delaying Novo's plans to launch the product until 2017, at the earliest. However, in August, Novo announced that its outcomes trial was progressing ahead of schedule. The company was on track to conduct an interim analysis by the end of this year, potentially allowing it to submit data to the FDA in the first half of 2015 and finally launch the product in the U.S. in 2016.

But on a conference call with analysts on Thursday, Novo was considerably less bullish. The company now says it hasn't yet decided whether to submit that interim data to U.S. regulators or hold out for the full study, meaning that 2017-or-later timeline is still in play. Novo will get its first peek at interim results in the middle of next year, Chief Science Officer Mads Krogsgaard Thomsen said on the call, and only then will it decide whether to head straight back to the FDA or wait out its multi-year DEVOTE study.

"Our confidence in the DEVOTE and the interim analysis is completely unabated and unchanged," Thomsen said, according to Reuters. "It is just a change in the strategy."

Novo's final decision will likely have major implications on the market for long-acting insulins, as Tresiba, already approved in Europe, is soon to face competition. Sanofi ($SNY) has submitted Toujeo, a longer-acting successor to top-selling insulin Lantus, for FDA approval, and Eli Lilly ($LLY) expects to file its rival peglispro for approval in the first quarter of next year.

The biggest potential for Novo's new insulin may be its role in an investigational combo therapy. Xultophy, which combines Tresiba with the blockbuster GLP-1 drug Victoza, came through with stellar Phase III results earlier this year, improving Type 2 diabetics' blood sugar without the weight gain associated with long-acting insulins. However, because the U.S. requires any combo product to be made up of two or more approved treatments, any further delay to Tresiba will only prolong Novo's ambitions.

- read the Reuters story

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