Novo Nordisk obesity drug gets EU approval
pharmafile | March 24, 2015 | News story | Sales and Marketing | EMA, EU, FDA, Victoza, liraglutide, obesity, saxenda
Novo Nordisk’s obesity drug Saxenda has been approved by the European Commission for use across the EU.
This approval follows a nod from the EMA in January and approval by the FDA in December. It allows the drug to be used in patients who have an initial body mass index (BMI) of more than 27 kg/m2 and at least one other weight-related problem – such as hypertension, dyslipidaemia or obstructive sleep apnoea.
The treatment is also required to be used in conjunction with a reduced-calorie diet and increased exercise.
“The approval of Saxenda in the EU is an important development for people with obesity,” says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “We believe it has the potential to help some of these people achieve and maintain clinically significant weight loss and improve their weight-related comorbidities.”
Earlier this month the Danish firm posted results from its SCALE trial suggesting that Saxenda (liraglutide 3mg) is more effective than a placebo at improving several of these comorbidities. However this is mainly due to the fact that it more likely to reduce weight, the root cause of these problems.
The drug’s active ingredient liraglutide is an analogue to glucagon-like peptide-1 (GLP-1), a hormone released in the body to regulate food intake by lowering appetite. GLP-1 receptor agonists such as this also stimulate insulin secretion and reduce blood glucose, and indeed Novo Nordisk also markets liraglutide in a lower dose as diabetes treatment Victoza.
The company says that Saxenda is the first once-daily GLP-1 analogue approved for the treatment of obesity in Europe.
It was one of only a few new obesity pills to be approved in the US in the last few years – the others include Orexigen’s Contrave in 2014, and Vivus’ Qsymia (phentermine/topiramate) and Arena’s Belviq (lorcaserin) in 2012. Prior to that, the last obesity treatment to be approved in the country was Roche’s Xenical (orlistat) in 1999.
All of these medicines have suffered a difficult path on the road to approval, with a number of FDA rejections and concerns from doctors over safety, notably the effect of these medicines on the heart.
Saxenda’s previous use as a diabetes treatment, however, means that analysts have more confidence in its market potential, and have predicted that it could generate $1 billion in revenue for Novo Nordisk.
Sanofi also has a GLP-1 receptor agonist in development, but it has hit several snags in the past. In its most recent study it showed no benefit in cardiovascular disease.
Obesity is thought to affect approximately 10-30% of adults in the EU. It is a complex disease that is influenced by genetic, physiological, environmental and psychological factors and is associated with serious health consequences and decreased life expectancy.
Novo Nordisk says that it expects to launch its drug in European markets later this year.
George Underwood
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