In April, Novo Nordisk announced it has successfully resubmitted Tresiba, a long-acting insulin, to the FDA for approval, according to a Fierce Pharma article.
In 2013, the FDA surprised Novo Nordisk officials when it rejected Tresiba due to concerns over cardiovascular risks. Novo has been conducting safety research ever since to allay the concerns of federal regulators. Tresiba has already launched in Europe, Mexico and Japan. If given the green light this time around, the basal insulin would be sold in the U.S. in 2015 or 2016, and it would be projected to generate $3 billion a year in global sales.
According to a Fierce Biotech report on Tresiba, Novo’s resubmission of Tresiba could backfire for a couple of reasons, say analysts. First, only a small group of employees has actually seen the new safety data. Secondly, the data is taken from an incomplete research study. However, the Denmark-based company is confident that the results they’ve collected so far are good enough. Also, if the company were to wait for full results, Tresiba’s launch would be delayed by a year.
If Tresiba is approved by the FDA, it will be another threat to the dominance of Lantus, Sanofi’s best-selling long-acting insulin. Novo Nordisk wants to get Tresiba to market before Sanofi’s own new long-acting insulin formula, Toujeo, has a chance to gain market share.
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