Novo Nordisk Sees FDA Tresiba Approval Taking 3 Years
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Novo Nordisk A/S, the world’s largest insulin maker, said it expects to overcome the rejection by U.S. regulators of the new Tresiba medicine within three to five years as the company conducts more tests.
Five years would be the “worst-case scenario,” Chief Financial Officer Jesper Brandgaard told reporters on a conference call today. A cardiovascular outcomes study requested by the Food and Drug Administration will start within a year and interim results the regulator could use to determine approval are expected within two to three years, Brandgaard said.