Novo Nordisk’s two diabetes drugs fail to win US FDA approval

Hannah Blake

pharmaphorum

It was announced over the weekend that on the 8th February, Novo Nordisk received a Complete Response Letter from the US FDA regarding the New Drug Applications (NDA) for its diabetes drugs Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart). A Complete Response Letter is issued by the FDA, when the agency determines that an application cannot be approved for use in the United States in its current form.

The FDA has requested additional cardiovascular data from a dedicated clinical outcomes trial before the review of the NDA can be completed. While Novo Nordisk has said it will work closely with the FDA to provide this data, it believes it will not be able to complete the request in 2013.

“We are convinced that Tresiba and Ryzodeg offer significant benefits for people who require insulin. We are surprised and disappointed to receive this letter, but we acknowledge this decision by the FDA and will work with the agency to determine the best path forward to completing the review.”

Lars Rebien Sørensen, chief executive officer of Novo Nordisk.

The New Drug Applications for Tresiba and Ryzodeg were submitted by Novo Nordisk to the FDA in September 2011. The two diabetes drugs are already approved in Japan, the EU and Mexico and are also under regulatory review in a number of other countries throughout the world.

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Related news:

Novo Nordisk Insulin Fails to Win FDA’s Backing (Bloomberg)

Novo Nordisk knocks Europe shares after U.S. setback (Reuters)

Reference links:

Novo Nordisk PDF

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