The FDA is requesting additional cardiovascular data from a dedicated cardiovascular outcomes trial from Novo Nordisk for insulin degludec (Tresiba) and insulin degludec/insulin aspart (Ryzodeg). Results must be available for review before the FDA will complete the new drug applications.
The FDA informed the Danish pharmaceutical company in a Complete Response Letter of its request. The agency also stated that approvals for Tresiba, a long-acting insulin, and Ryzodeg, a related product, cannot be granted until the violations cited in a warning letter dated a Dec. 12, 2012, have been resolved.
Novo Nordisk said it is evaluating the content of the complete response letter and will work with the FDA to provide the requested data. Bagsværd, Denmark-based Novo Nordisk does not expect to be able to provide the requested data during 2013.
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’s Endocrinologic and Metabolic Drugs Advisory Committee meeting, a panel 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 are approved in Japan, the European Union and Mexico.