Saxenda (Liraglutide) of Novo Nordisk received 14-1 positive vote for approval from EMDAC ( Endocrinologic an Metabolic Drugs Advisory Committee) of US FDA.
The panel members were asked to discuss whether Novo Nordisk has provided enough data to establish the safety and efficacy profile of Saxenda(Liraglutide) for chronic weight management based on the NDA data submitted.
Overall benefit-risk assessment of Saxenda(Liraglutide) got 14-1 votes from the panel members for weight management in patients with BMI 30kg/m2 or greater.
NDA for Saxenda(Liraglutide) was submitted on october 2013 with US FDA. The data submitted for NDA included phase 3 SCALET clinical trial in which 5000 people with obesity were involved.
The panel members were asked to discuss whether Novo Nordisk has provided enough data to establish the safety and efficacy profile of Saxenda(Liraglutide) for chronic weight management based on the NDA data submitted.
Overall benefit-risk assessment of Saxenda(Liraglutide) got 14-1 votes from the panel members for weight management in patients with BMI 30kg/m2 or greater.
NDA for Saxenda(Liraglutide) was submitted on october 2013 with US FDA. The data submitted for NDA included phase 3 SCALET clinical trial in which 5000 people with obesity were involved.