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FDA approval for Novo Nordisk's obesity shot

New formulation of diabetes drug Victoza will be marketed as Saxenda

Novo Nordisk US HQ

Novo Nordisk has won US approval for a new formulation of liraglutide, which it will brand as Saxenda as the Danish firm looks to enter into the tough but potentially lucrative obesity market.

A lower dose form of the drug is already approved in the US and sold as Victoza, which has a US licence for certain type II diabetes patients to help lower their blood sugar levels.

Trials of the drug have long shown it can also help reduce patients' weight, and the FDA has now licenced Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.

The drug is specifically approved for use in adults with a body mass index (BMI) of 30 or greater, or for adults with a BMI of 27 or greater who have at least one weight-related condition such as hypertension, type II diabetes, or high cholesterol.

A recent study showed that half the patients given Saxenda lost at least 5% body weight, the FDA said. Rival drugs show 2-5% weight loss, over and above diet and exercise.

The drug has already been a major success story for Novo Nordisk as a diabetes treatment, bringing in just over $2bn in sales last year, up 27% on its 2012 figures.

Its new licence will, according to analysts, help the drug deliver even more sales, with an extra $2.4bn in revenue expected to be brought in for the company.

This could be a game changer for the obesity market which has failed to be a major revenue driver for pharma since the first approval of Roche's Xenical (orlistat) in 1999.

In the last two years three other drugs have gained US marketing approval, including: Orexigen's Contrave, Vivus' Qsymia (phentermine/topiramate) and Arena Pharmaceuticals' Belviq (lorcaserin).

But they have so far failed to make any real market, with Xenical bringing in around $400m a year with the others failing to make $100m collectively.

Obesity is a large and growing problem in the US with many co-morbidities attached to those with higher BMI scores, and there is the potential for a new treatment to be a major blockbuster.

According to the US Centers for Disease Control and Prevention, two-thirds of American adults are overweight or obese and the prevalence of obesity in the US more than doubled among adults from 1980 to 2010.

All of the previously approved drugs have however had to tread a tough regulatory path due to their serious potential side effects, predominantly over their effects on the heart, which have pegged back their blockbuster potential.

High sales potential

This could all change with Saxenda as analysts expect the drug to do well given that it has been used for four years by doctors for diabetes, and has not faced the same cardiovascular safety concerns as many of its rivals (although there have been safety issues over its increased risk of pancreatitis).

But Saxenda does have some other issues as it does not come in pill form, as its rivals do, but rather as an injection, which could hamper sales.

Price may also be an issue as analysts expect the injection to be priced at about $40 per day - compared with an average of $5 to $6 per day for rival drugs.

However, the treatment is expected to have a better chance of being covered under Medicare and Medicaid drug payment programmes than rival drugs due to Victoza's established safety profile.

Article by
Ben Adams

24th December 2014

From: Sales



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