“Novo Nordisk Chief Executive Lars Rebien Sorensen said the company was “surprised and disappointed” by a letter it received Friday from the U.S. Food and Drug Administration demanding additional cardiovascular data. The Danish company, which is the world’s largest maker of insulin, said it doesn’t expect to be able to provide the information during 2013.
Shares of Novo Nordisk fell sharply Monday following the disclosure. The Danish drug maker said the FDA’s letter “is not expected to significantly impact Novo Nordisk’s expectations for the company’s financial results for 2013.”
The news comes less than two weeks after the company said the launch of Tresiba and a related product, Ryzodeg, was reason to be optimistic heading into 2013. Demand for insulin has been growing worldwide and Novo Nordisk’s new product is expected to sell at a premium over competitors’ drugs.
Novo Nordisk announced in January that Tresiba had been approved in the European Union. Launch in the U.K. and Denmark is to take place during the first half year of 2013, with other EU countries to follow through the end of 2014….”
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