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Novo Nordisk restarts obesity programme

Novo Nordisk will restart a global phase III development programme of its drug Victoza, for obesity, based on new feedback from the FDA

Novo Nordisk will restart a large-scale global phase III development programme of its drug Victoza (liraglutide), for the treatment of obesity, based on new feedback from the US Food and Drug Administration (FDA).

Liraglutide, which was approved by the FDA under the tradename Victoza as an adjunct to diet and exercise for the treatment of type II diabetes in early 2010, is a once-daily injection that lowers blood glucose by stimulating the release of insulin and lowering of glucagon secretion when blood sugar levels are high and also by slowing gastric emptying.

In addition, the drug reduces body weight and body fat mass through mechanisms involving reduced hunger and lowered energy intake.

The company halted the obesity programme for the drug last year after safety concerns were raised by the FDA. At the time, Novo Nordisk said it would postpone the research, involving around 5,000 subjects, until it was clear that the concerns would not get in the way of the drug ultimately being approved.

The US labelling for Victoza as a diabetes treatment includes a boxed warning, the strongest type of warning that the FDA can require, regarding the risk of thyroid c-cell tumours, which were linked to the drug in preclinical testing on rodents, although there were no reported cases of medullary thyroid carcinoma during the clinical trials.

In addition, Victoza is marketed in the US under a Risk Evaluation and Mitigation Strategy (REMS) programme that includes a Medication Guide for patients and a Communication Plan for healthcare providers discussing the risk of pancreatitis and the potential risk of MTC.

Now that the drug has been successfully approved and launched for diabetes, and following discussions with the FDA, the company said it would restart the obesity trials in the first half of 2011.

Novo Nordisk also said it plans to outline the clinical development programme for a once-weekly version of the injection in the second half of next year.

23rd June 2010

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