Sanofi has news for all of the payers, providers and patients who thought the French drugmaker would discount its newly approved insulin Toujeo to get it established in the market. Think again.
Novo Nordisk says the FDA has accepted its reapplication of its long-acting insulin Tresiba, setting it up for an October decision and a launch yet this year if approved this time around. Execs at Sanofi will certainly be watching the calendar just as closely given that a Tresiba launch will complicate the French drugmaker's efforts to its new long-acting insulin Toujeo established as the clear successor to aging Lantus.
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 CEO Lars Sorensen told investors today that 2014 had been a more challenging year than most, then rolled off a series of results that showed significant leaps in sales both in the U.S. and worldwide. He then waved off any worries about a price war in the U.S. being a significant issue for the world's largest maker of insulin products this year.
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 is hustling to get work done so that it can resubmit its blockbuster hopeful Tresiba to the FDA next year with an eye on getting into the market by 2016, three years after the FDA squelched its plans with its initial denial. In the meantime, Novo is finding new ways to combo Tresiba up and sell it in Europe where it is approved.
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.