Back in early 2013, the FDA stunned Novo Nordisk and the analysts covering the big diabetes drug player when regulators overrode their outside advisers and decided to require a cardio safety study of its long-acting insulin Tresiba. And now, as Novo steers its way toward a near-term reappraisal at the FDA, the company is ushering in some new data to support the combination of Tresiba and Victoza as analysts once again say an approval is all but certain.
Novo Nordisk executives led by President and CEO Lars Rebien Sorensen noted competition from local companies in China and Sanofi as the key reasons for weak sales in the Middle Kingdom in the second quarter.
Germany's tough price negotiators went too far for Novo Nordisk. The Danish drugmaker is pulling its new diabetes drug Tresiba off the market after authorities said they'd price the long-acting basal insulin on par with old human insulin injections.
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.