Novo Diabetes Trial Gets Good Results But Bad News From FDA

Novo Nordisk’s Phase III study of liraglutide for patients with Type 2 diabetes yielded promising results, but the drug may face an approval delay.

Participants in the study were randomized to receive the drug or placebo for 26 weeks in addition to metformin and rosiglitazone. Data show that patients who took the combination with liraglutide, a human GLP-1 analogue, had improved blood glucose levels, weight loss, blood pressure reduction and improvement in beta cell function, Novo says.

The company submitted an NDA to the FDA in May with the expectation of receiving an action letter next March following the standard 10-month review period. However, since the relevant advisory committee will meet shortly before this date, “the FDA has indicated that it will most likely have to extend the date of completing their assessment by a couple of months,” the company says in a statement.