Novo Nordisk: FDA approves inclusion of data.
(CercleFinance.com) - On Wednesday Novo Nordisk said its type-2 diabetes drug Victoza has received an FDA committee's approval for inclusion of cardiovascular data in the product label.
The endocrinologic and metabolic drugs advisory committee (EMDAC) voted 17-2 in favour on the question of substantial evidence set to establish that Victoza reduces cardiovascular risk in patients with type-2 diabetes.
In addition, all 19 members voted in favour of Victoza to consider that the drug is not associated with excess cardiovascular risk in patients with type-2 diabetes is not associated with excess cardiovascular risk.
The discussions were based on data from a trial which involved over 9,300 people with type-2 diabetes at high risk of major cardiovascular events.
Cardiovascular disease is the main cause of death for people with type-2 diabetes.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
The endocrinologic and metabolic drugs advisory committee (EMDAC) voted 17-2 in favour on the question of substantial evidence set to establish that Victoza reduces cardiovascular risk in patients with type-2 diabetes.
In addition, all 19 members voted in favour of Victoza to consider that the drug is not associated with excess cardiovascular risk in patients with type-2 diabetes is not associated with excess cardiovascular risk.
The discussions were based on data from a trial which involved over 9,300 people with type-2 diabetes at high risk of major cardiovascular events.
Cardiovascular disease is the main cause of death for people with type-2 diabetes.
Copyright (c) 2017 CercleFinance.com. All rights reserved.