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| Novo Nordisk's Tresiba |
Last year's surprising FDA rejection blew a hole in Novo Nordisk's ($NVO) plans to capitalize on a new long-acting insulin, but the Danish drugmaker said its follow-on study is coming through ahead of schedule, clearing the way for a 2016 launch.
The treatment, marketed in Europe as Tresiba, is a once-a-day insulin analog with a long duration of action. In late-stage data submitted to the FDA, Tresiba came through on its efficacy goals of reducing baseline blood glucose, but some troubling safety signals led the agency, notoriously strict on diabetes drugs, to strike down Novo's application and demand a cardiovascular outcomes study. The rejection sent Novo reeling and put off what seemed like a near-term launch into 2017 at the earliest, the company said at the time.
But that outcomes study is progressing ahead of plan, Novo said on its earnings call Thursday. The company now expects to kick off an interim analysis by year's end, potentially allowing it to submit data to the FDA in the first half of next year and finally launch the product in the U.S. in 2016.
That's good news for a treatment expected to peak at more than $3 billion a year in global revenue, a cornerstone of Novo's next-generation diabetes portfolio. And the accelerated timing should help Novo contend with its fast-encroaching rivals. Sanofi ($SNY) just submitted Toujeo, successor to top-selling insulin Lantus, for FDA approval, and Eli Lilly ($LLY) expects to file its long-acting peglispro for approval in the first quarter of next year. And the pair's ongoing legal squabble will likely keep a Lantus biosimilar off the U.S. market until at least mid-2016, preserving pricing as Novo gears up for commercialization.
But 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.
The European Medicines Agency is expected to approve Xultophy in the next few months, and Tresiba's ahead-of-schedule outcomes study is a balm to Novo's hopes for the cocktail in the U.S. The agency requires any combo product to be made up of two or more approved treatments, so until Tresiba gets a final OK, Xultophy will have to sit on the shelf.
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