Victoza pack

Novo to challenge NICE Victoza guidance

pharmafile | February 15, 2010 | News story | Sales and Marketing NICE, Novo Nordisk, Victoza 

NICE has given a partial green light to Novo Nordisk’s type II diabetes treatment Victoza, backing its use as part of a triple therapy combination.

In this preliminary judgment, NICE has not recommended the 1.8 mg dose of the drug – a position that the manufacturer says it will challenge.

The cost effectiveness watchdog has so far refused to back the 1.2 mg dose as part of a dual therapy and requested further clarification on this from Novo Nordisk.

Novo said it is “confident that we can provide the information requested and answer any further questions that may follow to support a recommendation in this group of patients”.

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Subject to that, the 1.2 mg daily dose is expected to be recommended for use in combination with metformin and a sulfonylurea, or metformin and a thiazolidinedion, when final guidance comes in the summer

NICE says treatment in a triple therapy regime should only continue if a person has lost at least 3% of their initial body weight at six months.

“NICE have seen the value of liraglutide and the major benefits that it has for patients with type 2 diabetes,” says Novo Nordisk’s UK and Ireland managing director Viggo Birch. “We are very encouraged by the preliminary recommendation.”

NICE says patients should generally have a Body Mass Index (BMI) above 35 to use the drug, but it may be used in others if insulin would have occupational implications or weight loss would benefit other obesity-related problems.

Launched in Europe last year, Victoza (liraglutide) is an injectable GLP-1 agonist receptor analogue designed to work along existing oral treatments.

It lowers glucose levels by stimulating the release of insulin when glucose levels become too high, and also inhibits appetite.

The drug has also been licensed in the US and Japan, and a trial to turn Victoza into a pill began in January.

The need to inject it represents a possible barrier to take-up, but it is the first GLP-1 analogue with a 24-hour duration of action developed for type 2 diabetes and a global roll-out is expected this year.

Victoza’s potential competitors include Amylin and Lilly’s GLP-1 agonist Byetta LAR (exenatide).

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