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Positive data in Saxenda diabetes prevention study

Drug found to improve blood glucose and blood pressure levels

Novo Nordisk headquarters 

Patients who lose weight when treated with Novo Nordisk's obesity drug Saxenda also show improvements in blood glucose and blood pressure levels, according to a clinical trial.

One of the main goals of the trial is to see if long-term treatment with Saxenda (liraglutide) will help delay the onset of type 2 diabetes, although data on this outcome will not be ready until later.

The initial results from the SCALE trial are however encouraging. 63% of patients treated with a once-daily Saxenda shot on top of calorie restriction and physical activity achieved a 5% or more weight reduction after 56 weeks, compared to 27% of those who were treated with placebo plus diet and exercise.

Moreover, those who responded to treatment with Novo's drug showed reductions in fasting plasma glucose, waist circumference, systolic blood pressure and quality of life as measured by the Short Form Health Survey (SF-36).

The phase IIIa trial involved 3,731 overweight or obese adults who were not diabetic, but had other weight-related problems such as high blood pressure or elevated cholesterol levels. The drugs impact on the development of diabetes will be assessed after patients have been followed up for 160 weeks.

The results were presented at the annual meeting of the Endocrine Society (ENDO) in San Diego.

"Many people with obesity are unaware of its severity and its implications for their health," said lead investigator Patrick O'Neil of the Medical University of South Carolina in Charleston, US."

"The nature of this disease is complex and maintaining weight loss can be challenging [and] multiple treatment options are needed to help people with obesity lose weight, keep it off, and improve their health."

The positive effects of Saxenda on blood pressure and blood glucose are encouraging, but SCALE also reinforces the positive effect on weight seen in registration trials for the drug. All told, a third of patients on Saxenda lost 10% or more of their body weight, compared to 10% of the placebo group.

Saxenda - which is a high-dose formulation of the same drug used in Novo's big-selling diabetes therapy Victoza - was approved for obesity in the US towards the end of last year and has also been recommended for approval in Europe.

Analysts have suggested that the product could achieve sales of $1bn or more, succeeding in revitalising the market for weight-loss drugs which remains fairly static despite the recent launches in the US of three other drugs; Eisai and Arena's Belviq (lorcaserin), Vivus' Qsymia (phentermine/topiramate) and Orexigen's Contrave (naltrexone and bupropion).

None of these has made significant headway since their US launches, and of the three only Orexigen's drug (branded as Mysimba) has been backed in Europe, with both Belviq and Qsymia turned down by the European Medicines Agency (EMA) on safety concerns.

Novo said recently it expects to launch Saxenda in the US in the first half of 2015 and in several EU markets before the end of the year, with "modest" sales contribution in the early months. The company will put 500 sales reps behind the product in the US, targeting what it describes as a "relatively narrow" group of weight management specialists.

Article by
Phil Taylor

10th March 2015

From: Research



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