Novo Nordisk A/S NVO announced the presentation of new data from the phase IIIa SCALE Obesity and Prediabetes study on Saxenda at The Endocrine Society’s Annual Meeting.
According to the new data, patients suffering from obesity or overweight patients with comorbidities, who had lost ≥5% of their body weight at week 56 in the above study (classified as weight loss responders), further achieved greater improvements across a range of efficacy outcomes with Saxenda treatment (in combination with a reduced-calorie diet and increased physical activity) compared with those who had lost less than <5% of their body weights.
Novo Nordisk said that responders under Saxenda treatment showed greater improvement in fasting plasma glucose (compared with responders on placebo and non-responders), greater reduction in systolic blood pressure (compared with responders and non-responders receiving placebo) and improvements in physical health scores (compared with non-responders). Apart from improvement in cardiometabolic risk factors, responders showed better quality-of-life outcomes compared to non-responders (for Saxenda as well as placebo).
The company stated that in the SCALE Obesity and Prediabetes study, 63.2% of the patients treated with Saxenda achieved a clinically meaningful body weight reduction of at least 5% compared to only 27.1% of those who received placebo. On average, weight loss for responders undergoing Saxenda treatment was 11.7% while that in non-responders was 1.7%. For the patients administered with placebo, average weight loss in responders was 10% while non-responders showed a weight gain of 0.1%.
We note that Saxenda is already approved in the U.S. as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in patients suffering from obesity or overweight patients with at least one weight-related comorbidity.
Meanwhile, Saxenda, which is under the European Commission’s review, received a positive opinion from the Committee for Medicinal Products for Human Use on Jan 22, 2015. A decision regarding Saxenda’s marketing authorization in the EU is expected by Apr 2015.
Other drugs already approved by the FDA include Arena Pharmaceuticals ARNA/Eisai’s Belviq and Takeda TKPYY/Orexigen’s OREX Contrave.
Novo Nordisk carries a Zacks Rank #4 (Sell). Takeda holds a Zacks Rank #2 (Buy).
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