FDA Wants Cardiovascular Safety Data Before Approving Insulin Degludec

February 11th, 2013

FDA Wants Cardiovascular Safety Data Before Approving Insulin Degludec

Larry Husten, PHD

The FDA informed Novo Nordisk on Friday that it would not approve the company’s highly anticipated long-acting insulin degludec products (Tresiba and Ryzodeg) until it receives data from a cardiovascular outcomes trial. Approval of the drugs had been widely anticipated for this year, following a positive recommendation from an FDA advisory committee last fall. But the committee also unanimously recommended that the company be required to perform a cardiovascular outcomes trial.

In a Complete Response Letter, the FDA told Novo Nordisk that it will require “additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications can be completed.” In a press release, Novo Nordisk said it did not expect it would be able to supply the requested data this year. Sanford Bernstein analyst Timothy Anderson speculated that the earliest possible date for approval is now 2015. Anderson also noted that the delay for insulin degludec would help to bolster Sanofi’s insulin glargine (Lantus) franchise.

Novo Nordisk CEO, Lars Rebien Sørensen, said: “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.”

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February 11th, 2013