The European Commission (EC) has approved the use of Merck Sharp & Dohme Limited's (MSD) Januvia as the top restricted first-line treatment for type 2 diabetes.
Januvia (sitagliptin) is now the only diabetes treatment in the DPP-4 inhibitor class approved for first-line use in the EU.
The treatment is now licensed to improve glycaemic control in situations where diet and exercise alone do not provide adequate glycaemic control and also when the use of metformin is inappropriate due to contraindications or intolerance.
MSD Diabetes spokesperson Paul Leigh said that the recognition builds on the recent NICE guideline on newer agents in type 2 diabetes.
"As the first approved medicine in the DPP-4 class of oral treatments, with 12 million prescriptions already written globally to date, we are proud of the leadership role MSD has played in exploring how best this class of medicines can be utilised to manage type 2 diabetes," Leigh said.
"We are pleased that the EC has recognised the benefits of sitagliptin by broadening the licensed indications."
Sitagliptin is a highly selective, once-daily DPP-4 inhibitor that enhances natural body systems, to help regulate blood sugar by increasing levels of active GLP-1 and GIP hormones.
The EC approval for restricted first-line use was based on positive feedback by the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP).