First once-daily GLP-1 analogue receives positive opinion from European regulatory authorities Novo Nordisk announces that the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMEA) adopted a positive opinion, recommending marketing authorisation, for Victoza® for the treatment of type 2 diabetes.
Victoza® is the brand name for liraglutide, the first once-daily human Glucagon-like peptide-1 (GLP-1) analogue developed for the treatment of type 2 diabetes.
The positive opinion for Victoza covers:
- combination treatment with metformin or a sulphonylurea in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea, (ie second-line use after one oral agent), and
- combination treatment with metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycaemic control despite dual therapy (ie third-line use after two oral agents).
Novo Nordisk expects to receive final marketing authorisation from the European Commission within approximately two months. Subject to the Commission’s approval, Novo Nordisk expects to launch Victoza in selected European markets, including the UK, in Q3.
“With the recent announcement of a positive opinion from the CHMP, we are optimistic that Victoza will soon be approved for patients with type 2 diabetes, providing a valuable new therapy and improving treatment options for patients in the UK,” said Viggo Birch, Managing Director, Novo Nordisk UK and Ireland.
“We are very much looking forward to the availability of Victoza for our patients in the UK,” said Professor Steve Gough, Selly Oak Hospital, Birmingham. “There is no doubt that there is a great unmet need for a treatment with Victoza’s benefits and physicians in the UK are very encouraged by data from the comprehensive and extensive LEAD (Liraglutide Effect and Action in Diabetes) clinical study programme”.