Novo Nordisk's Victoza 3 mg Positive in Phase III

Novo Nordisk A/S’s (NVO) Victoza (liraglutide 3 mg) showed statistically significant primary results in the randomized, placebo-controlled, double-blind, phase IIIa SCALE Diabetes study (n=846) for chronic weight management.

Victoza (once-daily), along with proper diet and physical activity, showed greater weight loss at 56 weeks compared with placebo, in type II diabetic patients who are overweight or suffering from obesity. In the study, 49.9% of the patients treated with Victoza 3 mg achieved at least 5% weight loss compared to 35.0% of the patients treated with Victoza 1.8 mg and 12.7% of the patients treated with placebo.

Moreover, Victoza 3 mg led to a significant reduction (-1.3%) in blood glucose (HbA1c) from baseline compared to placebo (-0.4%). A significantly higher percentage of patients (72.3%) achieved the HbA1c target of less than 7% under treatment with the drug compared to placebo (22.9%).

We note that Victoza 3mg is currently under review in the U.S. and the EU. Novo Nordisk is looking to get Victoza 3mg approved for chronic weight management in overweight adults or those suffering from obesity along with comorbidities, as an adjunct to a reduced-calorie diet and increased physical activity.

Victoza is already approved at lower doses as an adjunct to diet and exercise for the treatment of type II diabetes for improving blood glucose control.

We note that in another double-blind, randomized, controlled, 26-week long phase III study (n=277), Novo Nordisk showed that treatment with Victoza (once-daily, 1.8 mg) led to greater glycemic control in type II diabetic adults suffering from moderate renal impairment compared to placebo, without worsening of renal function. Patients treated with Victoza (average age of 68 years) showed a lower incidence of hypoglycemia compared to placebo.

Additionally, one-year data from a phase IIIa study on IDegLira, the once-daily single injection combination of Tresiba (insulin degludec) and Victoza, showed that the glucose-lowering effect was maintained in patients after a year of treatment.

Although patients treated with IDegLira showed a 37% lower rate of hypoglycemia compared to insulin degludec, liraglutide-treated patients showed lesser incidence of this emergency.

Novo Nordisk presented the above data at the 74th Annual Scientific Sessions of the American Diabetes Association (:ADA).

We are pleased to see Novo Nordisk's progress with its diabetes drug. Novo Nordisk needs to bring new products to market considering that Prandin is facing generic competition.

Novo Nordisk carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector include Allergan Inc. (AGN), Gilead Sciences Inc. (GILD) and Quintiles Transnational Holdings Inc. (Q). While Allergan and Gilead hold a Zacks Rank #1 (Strong Buy), Quintiles carries a Zacks Rank #2 (Buy).

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