FDA approves labeling change for Novo Nordisk diabetes drug


PRINCETON, N.J. — The Food and Drug Administration has approved a change to the label of a Novo Nordisk drug stating that it offers superior blood-sugar control to a competing drug made by Merck, based on results of two clinical studies, Novo Nordisk said Monday.

The drug maker announced that the FDA had approved the change for the labeling of Victoza (liraglutide [rDNA origin]) to state that the drug works better than Januvia (sitagliptin) in patients with Type 2 diabetes when either drug is taken with the generic drug metformin. The new labeling also includes data stating the safety and efficacy of the drug when combined with Novo Nordisk's basal insulin Levemir (insulin detemir [rDNA origin]).

"We're pleased to expand the Victoza product label to include data demonstrating superior efficacy over Januvia," Novo Nordisk corporate VP diabetes marketing Camille Lee said. "The additional data supporting combination therapy with basal insulin further demonstrates that Victoza is an appropriate option for a wide variety of adults with Type 2 diabetes."

The label change is based on two clinical studies showing that patients who took Victoza experienced reductions in blood sugar of 1.2% to 1.5%, compared with 0.9% in patients taking Januvia, while Victoza also produced greater weight loss — 5.9 lbs. to 7.3 lbs., compared with 1.8 lbs. in the Januvia group. Meanwhile, patients who added Levemir to their Victoza and metformin regimens reduced their blood sugar by a further 0.5%, while 43% of those taking Levemir reached the American Diabetes Association's blood sugar control target of less than 7%, compared with 17% of those taking Victoza and metformin alone.


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