(Reuters) - Denmark’s Novo Nordisk is to resubmit its new insulin Tresiba to U.S. regulators based on interim analysis data from a clinical trial, bringing its biggest new drug hope closer to the world’s top market.
Shares in the company leapt 13 percent to an all-time high in early trade in Copenhagen on Friday after it said it would file with the U.S. Food and Drugs Administration (FDA) within the next month. The drug was rebuffed by the FDA two years ago.
The plan, announced late on Thursday, is a big relief to investors, since a decision not to use the early data on Tresiba and related drug Ryzodeg would have further delayed a U.S. launch. Tresiba is already available in Europe and other markets.
Novo, the world’s top insulin maker, is now in a position to get a U.S. approval for Tresiba as soon as October or November, putting it on track to launch by early 2016, according to industry analysts.
Citigroup’s Peter Verdult said he believed the odds of U.S. approval were greater than 90 percent, given a small group of Novo staff sitting behind a communications “firewall” had already discussed the data with FDA.
The FDA asked Novo to conduct a dedicated cardiovascular risk trial, known as DEVOTE, after refusing to approve Tresiba in 2013 because of worries it might be linked to higher rates of heart attacks or strokes.
Novo had previously said it would decide during the first half of this year whether to submit interim or full trial results. Waiting for full results would have scuppered its hope of getting to market in 2016 and put it behind in a highly competitive sector.
Novo vies with Sanofi and Eli Lilly in supplying insulins to diabetics. A Tresiba launch in the United States within the next year may help see off rival products, notably Sanofi’s new insulin Toujeo, which is designed to succeed the French company’s Lantus.
Tresiba, an ultra-long-acting form of insulin that is also known as degludec, is currently forecast to generate annual sales of $2.2 billion by 2020, according to consensus estimates compiled by Thomson Reuters Cortellis.
But that number could rise as confidence in the product’s prospects now increases.
Editing by David Holmes and Mark Potter