Drug firm Merck said Thursday its type
2 diabetes drug Januvia has been recommended for approval in
the European Union.
The company said it has received a positive opinion from the Committee for Medicinal Products for Human Use -- part of the EU's European Medicines Evaluation Agency -- which recommended the first-in-class DPP-4 inhibitor be approved in Europe for type 2 diabetes.
Merck said it expects full marketing approval for Januvia in early April.
The diabetes treatment is currently approved in
11 other countries.
In October 2006 Januvia has been cleared as a monotherapy
and as add-on therapy to either metformin or thiazolidinediones
to improve blood-sugar control in type 2 diabetes patients when
diet and exercise are not enough.
Januvia works by enhancing the body's own ability to lower blood sugar when it is elevated, Merck said.