Novo Nordisk ($NVO) bolstered its better-late-than-never case to win FDA approval for a new long-acting insulin, as the drug, Tresiba, met its main goals in a study on children with Type 1 diabetes.
The injection, vital to Novo's continued dominance in diabetes, proved itself safe and effective in a 52-week study, adequately controlling blood sugar while matching the efficacy of the company's older Levemir. Unlike its twice-a-day predecessor, Tresiba has a duration of action of up to 40 hours, longevity the company believes will help it stand out in a top-heavy insulin market.
And the new pediatric safety data should help Novo make its second case to the FDA. Last year, the agency rejected the company's application over some alarming safety signals that outshone Tresiba's impressive efficacy data, telling Novo not to come back until it had real-world outcomes data on its candidate.
In the initial fallout, Novo feared that could put off a U.S. Tresiba launch until mid-2017, but the company disclosed last month that its outcomes trial is progressing ahead of schedule. 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 welcome news for a long-lasting insulin expected to bring in more than $3 billion a year at its peak, making it a cornerstone of Novo's next-generation diabetes portfolio.
And FDA approval can't come soon enough. Novo rival Sanofi ($SNY) just submitted Toujeo, successor to its top-selling Lantus, for FDA approval, and Eli Lilly ($LLY) expects to file its long-acting peglispro for approval in the first quarter of next year.
Meanwhile, Novo needs an agency approval for Tresiba before it can start making stateside headway on a promising combination product. Xultophy, which combines the new insulin 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 the combo 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 combination product to be made up of two or more approved treatments, so until Tresiba gets a final OK, Xultophy will have to wait.
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