Novo Nordisk's 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.
After a surprise FDA rejection sent it back to the drawing board in 2013, Novo Nordisk is finally ready to resubmit Tresiba, a long-acting insulin with blockbuster potential.
Novo Nordisk is sounding a more cautious tone on Tresiba, its once-rejected new insulin. After hinting at an accelerated trip back to the FDA for the long-acting diabetes treatment, the Danish drugmaker now says it could be another few years before the injection is ready for another shot at approval.
Novo Nordisk 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.
Danish financial regulators took a dim view of Novo Nordisk's decision to spend the weekend pondering the FDA's February 2013 snub to Tresiba before spreading the news of the agency's complete response letter and the major delay that would be triggered by its demand for a new study. And today Novo said it had decided to accept a $90,000 fine to close the books on the incident, not the least bit chastened at the slap on the hand.
The executive team here at the rapidly expanding headquarters of Novo Nordisk doesn't pull many punches. CEO Lars Rebien S ø rensen is a competitive sort who tends to be blunt, aggressive and forward-thinking; projecting a confident attitude that is reflected by the rest of the execs and right down the line to 40,000 rank-and-file employees around the world.
Last year's surprising FDA rejection blew a hole in Novo Nordisk's 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.
Last year's stinging FDA rejection for Novo Nordisk's Tresiba wiped billions off the drugmaker's market cap, but, despite getting bogged down with new safety studies, the company believes it can still get its long-acting insulin on the market before its rivals can settle in.
As a major medical meeting brings the spotlight to new diabetes drugs this month, Sanofi has begun reaching out to the media to secure center-stage status for data on its new therapies. The French drug giant has a next-generation version of its best-selling insulin drug Lantus as well as a combo therapy that have implications for its future in the market.
The FDA has handed Novo Nordisk a stunner, ordering the pharma company to complete a new cardiovascular safety study of the long-acting insulin Tresiba before it can be approved in the U.S.