Novo Nordisk's ($NVO) comeback plan for the long-acting insulin Tresiba took another step forward, as the FDA accepted the Danish drugmaker's resubmitted application and cleared the way for a potential approval this year.
The agency rejected Novo's product in 2013 over safety concerns, demanding long-term cardiovascular outcomes data before it would reconsider and seemingly putting off Tresiba's market debut until 2017 at the earliest. In the past few months, however, Novo has rapidly accelerated that timeline, handing in a new application based on interim outcomes data and betting it has found a shortcut to market with a product meant to serve as a cornerstone of its future in diabetes.
Novo's outcomes study isn't scheduled for completion until the second half of 2016, but a small group of researchers who saw data from a planned interim analysis believe Tresiba has already demonstrated its safety. The company's management, which hasn't seen the interim results, is taking them at their word, resubmitting the insulin and hoping the FDA agrees.
Tresiba's second go qualifies as a Class II resubmission under FDA guidelines (PDF), and the agency's acceptance kicks off a 6-month review process.
If Tresiba wins approval, Novo would finally get a chance to live up to peak sales estimates that value the insulin at around $3 billion a year. The once-a-day product is already approved in Europe, as is a combination of Tresiba and the blockbuster GLP-1 drug Victoza that analysts say could further boost the insulin's value. In the U.S., Novo won't be able to file that cocktail, called Xultophy, until each component is approved.
Elsewhere, the landscape in diabetes has shifted since Novo's first Tresiba setback. In February, Sanofi ($SNY) won U.S. approval for Toujeo, a daily insulin designed to usurp its top-selling Lantus. 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. Eli Lilly ($LLY), 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.
- read the announcement (PDF)