US FDA approvals for Novo Nordisk's Victoza and BioSpecific's Xiaflex

The US Food and Drug Administration yesterday granted marketing authorization for Danish insulin giant Novo Nordisk's Victoza (liraglutide) for the treatment of type 2 diabetes in adults, and also for US firm BioSpecific Technologies' Xiaflex (collagenase clostridium histolyticum) for a debilitating hand condition.

In the USA, Victoza is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. This provides for the drug to be used in monotherapy, (although not as first line therapy) and in combination with commonly prescribed oral medications for diabetes.

In Europe, Commission granted marketing authorization for liraglutide on June 30, 2009, for all 27 European Union member states. It has been on the market in the UK since July 7 last year. According to the EU authorization, liraglutide is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with: metformin or a sulphonylurea in patients with insufficient glycemic control despite maximal tolerated dose of monotherapy with metformin or sulphonylurea; and metformin and a sulphonylurea or metformin and a thiazolidinedione in patients with insufficient glycemic control despite dual therapy.