Novo Nordisk has received a complete response letter from the US Food and Drug Administration (FDA) regarding the new drug applications for 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 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.
In the letter, the FDA also states that approvals for Tresiba and Ryzodeg cannot be granted until the violations cited in the previously announced Warning Letter, dated December 12, 2012, have been resolved.
"We are convinced that Tresiba and Ryzodeg offer significant benefits for people who require insulin", said Lars Rebien Sørensen, chief executive officer of Novo Nordisk. "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."
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 favour of approving the products with a post-approval cardiovascular outcomes trial commitment.
Tresiba and Ryzodeg are approved in Japan, the EU and Mexico and under regulatory review in a number of countries throughout the world.
Date: February 10, 2013
Source: Novo Nordisk