November 21, 2012
Longer Acting Insulin Moves Closer to FDA Approval

Washington, D.C.—New ultra-long-acting insulin for type 1 and type 2 diabetes moved a step closer to approval this month, with a nod from an FDA advisory committee.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee was asked to consider new drug applications for insulin degludec (Tresiba) and insulin degludec/insulin aspart (Ryzodeg). It unanimously recommended that a cardiovascular outcomes trial should be conducted and voted 8 to 4 to recommend approval of the products with a postapproval outcomes trial commitment.

“The positive vote from the advisory committee marks an important step toward making insulin degludec and insulin degludec/insulin aspart available to adult patients with diabetes in the U.S. We look forward to completing the regulatory process with the agency, including the design of the post-approval cardiovascular outcomes trial,” said Alan Moses, MD, global chief medical officer of Novo Nordisk.

Degludec has been promoted as a new-generation, ultra-long-acting basal insulin, with an extended duration of action and lower incidence of hypoglycemic events in patients with both type 1 and type 2 diabetes.

Its unique mechanism of action is based on multihexamer formation after subcutaneous injection, which reportedly allows for less pharmacodynamic variability than currently available insulin analogs and a duration of action of more than 24 hours, according to a recent published review.

Novo Nordisk said it has not been informed when the FDA plans to complete review of the new drug applications, but said in interviews with media outlets that it anticipated approval early next year.

The approval applications were referred to the advisory committee after the FDA said it found a suggestion of an excess risk of cardiovascular events with degludec compared with other insulins in a review of 16 trials.

The FDA originally had announced it would reach a decision by October.

Novo Nordisk received approval for the formulation in Japan this fall and has been recommended for approval in Europe.

U.S. Pharmacist Social Connect