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FDA Rejects Two Insulin Products, Requests New Cardiovascular Trial

Previous warning letter cited (Feb. 10)

The FDA has turned down new drug applications (NDAs) for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) — both developed by Novo Nordisk.

In its complete response letter, the agency requested additional data from a dedicated cardiovascular outcomes trial before review of the NDAs can be completed. Novo Nordisk does not expect to be able to provide the requested information during 2013.

In the letter, the FDA also stated that approvals for Tresiba and Ryzodeg cannot be granted until violations cited in a previously announced warning letter — dated December 12, 2012 — have been resolved. The Dec. 12 letter said an inspection of the company’s drug-making factory in Denmark found significant violations of good manufacturing practice (CGMP) regulations.

The NDAs for Tresiba and Ryzodeg were submitted to the FDA in September 2011. In November 2012, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended that a cardiovascular outcomes trial should be conducted. The committee voted 8 to 4 in favor of approving the products with a post-approval cardiovascular outcomes trial commitment.

Sources: Novo Nordisk; February 10, 2013; and FDA; December 12, 2012.

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