Novo Nordisk (NVO) announced that the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted in favor (14-1) of approving its experimental obesity treatment, Saxenda (proposed brand name for liraglutide 3 mg). Novo Nordisk is looking to get Saxenda approved for chronic weight management in patients with either a BMI of ≥30 kg/m2, or a BMI of ≥27 kg/m2 plus at least one weight-related comorbid condition.
The EMDAC evaluated data from studies on Saxenda (including the phase III SCALE study) to determine whether Novo Nordisk has provided sufficient evidence regarding the efficacy and safety of Saxenda for chronic weight management.
Additionally, the Committee considered data related to the clinical trial and post-marketing experience of Victoza (liraglutide 1.8 mg), which is approved as an adjunct to diet and exercise for treating adults suffering from type II diabetes to improve blood glucose control, to assess the safety database of Saxenda.
Based on its evaluation, the Committee provided a clear recommendation on the overall benefit-risk profile of Saxenda. Saxenda received a 14-1 vote from the panel members implying that the Committee is in favor of the approval of Saxenda for chronic weight management in patients with either a BMI of ≥30 kg/m2, or a BMI of ≥27 kg/m2 plus at least one weight-related comorbid condition.
According to the American Medical Association, obesity is associated with serious comorbidities including type II diabetes, heart disease, obstructive sleep apnea, certain types of cancer as well as reduced life expectancy and hence requires chronic management. In the U.S., nearly 35% of the adult population (almost 100 million patients) suffers from obesity.
We are encouraged by the EMDAC’s opinion on Saxenda and believe that chances of gaining approval are high. Although the FDA is not bound to accept the recommendations of the EMDAC, it usually does so. The FDA review of Saxenda is expected to be completed by Oct 20.
However, the market for obesity is already crowded with products like Belviq and Qsymia. Earlier this week, the FDA approved Orexigen (OREX)/ Takeda’s (TKPYY) Contrave as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management. Contrave is expected to be launched in the fall of 2014.
Novo Nordisk carries a Zacks Rank #4 (Sell). A better-ranked stock in the health care sector is Allergan Inc. (AGN), carrying a Zacks Rank #1 (Strong Buy).
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