FDA committee votes in support of Saxenda for Obesity-Novo Nordisk
Novo Nordisk has announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA has completed its meeting regarding the New Drug Application (NDA) for Saxenda (liraglutide) 3 mg, a once-daily human GLP-1 analogue for the treatment of Obesity. Saxenda was filed with both the FDA and EMA in January 2014.
The submissions for liraglutide include data from the Phase III SCALE clinical trial programme, which involved more than 5,000 people with Obesity or who are Overweight with comorbidities. In addition to the data from the SCALE programme, data from earlier development phases and data related to the use of liraglutide in Type 2 Diabetes were also included in the submissions.
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