Novo Nordisk speeds back to the FDA with its once-rejected insulin

After a surprise FDA rejection sent it back to the drawing board in 2013, Novo Nordisk ($NVO) is finally ready to resubmit Tresiba, a long-acting insulin with blockbuster potential.

Tresiba's initial rejection centered on some alarming safety signals, and Novo kicked off a cardiovascular outcomes trial with the goal of amassing long-term data to demonstrate the insulin's tolerability. And waiting on full results would push Tresiba's potential launch back to 2017 at the earliest, allowing next-generation products from rivals Sanofi ($SNY) and Eli Lilly ($LLY) to get entrenched in the U.S. market.

Now, however, looking at an interim analysis of the outcomes trial, Novo believes it has enough positive data to make the case for Tresiba's safety before full results are available, and the Danish diabetes giant plans to resubmit the insulin within the next month. The move is something of a leap of faith for Novo, as only a small team of employees has actually seen the data, the company said--a group that doesn't include management.

If approved, Tresiba would hit the U.S. market some time next year, finally giving Novo a chance to live up to peak sales estimates that value the insulin at around $3 billion a year. The once-a-day product is already approved in Europe, as is a combination of Tresiba and the blockbuster GLP-1 drug Victoza that analysts say could further boost the insulin's value. In the U.S., Novo won't be able to file that combo, called Xultophy, until each component is approved.

Meanwhile, the landscape in diabetes has changed since Tresiba's FDA rejection. Last month, Sanofi won U.S. approval for Toujeo, a daily insulin designed to usurp its top-selling Lantus that the French company plans to launch in April. Analysts worry that the prospect of multiple new insulins competing for market share could lead to a value-destroying price war, and Novo, by coming in second, will miss out on a first-mover advantage. Lilly, at work on a daily insulin of its own, ran into a major setback last month as safety concerns forced it to delay an FDA filing for its candidate.

Novo, the world's top insulin maker, has continued to pour money into its diabetes R&D operation. Last year, the company unveiled plans for a $130 million diabetes research hub in its native Denmark, planning to house about 350 scientists when it opens next year. Novo's anchor drug remains Victoza, which brought in more than $2 billion last year, and the drugmaker is working through Phase III with a weekly GLP-1 treatment called semaglutide and a faster-acting formulation of the top-selling insulin NovoLog.

- read the statement (PDF)

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