FDA Delays Review of Novo Nordisk’s New Drug Applications for Tresiba and Ryzodeg

The U.S. FDA issued a Complete Response Letter regarding the New Drug Applications for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) informing Novo Nordisk that an application cannot be approved in its current form.
In the letter, the FDA requests additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications can be completed. Novo Nordisk is evaluating the content of the Complete Response Letter and will work closely with the FDA to provide the requested data. Novo Nordisk does not expect to be able to provide the requested data during 2013.

The FDA also states that approvals for Tresiba and Ryzodeg cannot be granted until the violations cited in the previously announced Warning Letter, dated 12 December 2012, have been resolved.

The New Drug Applications for Tresiba and Ryzodeg were submitted by Novo Nordisk to the FDA in September 2011. In November 2012, at an FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting, a panel of independent scientific experts unanimously recommended that a cardiovascular outcomes trial should be conducted and voted eight to four in favor of approving the products with a post-approval cardiovascular outcomes trial commitment.

Tresiba and Ryzodeg were approved in Japan, the EU and Mexico and are under regulatory review in a number of countries throughout the world.

The Complete Response Letter is not expected to significantly impact Novo Nordisk’s expectations for the company’s financial results for 2013, which were provided on 31 January 2013 in connection with the release of the financial results for 2012.

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