Merck, Sharp & Dohme’s Januvia, a once-daily pill that lowers blood sugar levels in people with type 2 diabetes, has been endorsed by the Scottish Medicines Consortium for restricted use on the country’s National Health Service.

The DPP-4 blocker is the first in a new class of type 2 diabetes therapies that enhance the body's own ability to keep blood sugar levels balanced. Januvia was approved in both Europe and the USA in April this year for patients with type 2 diabetes mellitus to improve blood sugar control, as an add-on to metformin or a thiazolidinedione (glitazone) when diet and exercise or therapy alone are not getting adequate results.

The SMC says use of the drug should be restricted to patients for which the addition of sulphonylureas to therapy is not appropriate.

Approval of the first DPP-4 blocker earlier this year caused quite a stir of excitement, given that clinical evidence demonstrates that its mode of action - based on enhancing pancreatic islet cell function to promote insulin secretion and inhibit glucagon production – is very effective in controlling blood sugar levels. Furthermore, the agent has a solid safety profile and is not associated with the weight gain often seen with other diabetes medications.

“Many patients fail to achieve adequate diabetes control putting them at increased risk of long term complications. This is in part contributed due to limitations of current therapies and concerns about weight gain and hypoglycaemia, as well as tolerability issues,” explained Professor Anthony Barnett from Birmingham Heartlands Hospital. “It is excellent news that we now have another class of oral agents to increase the choice of compounds for our patients, particularly since sitagliptin appears to have an excellent tolerability profile with weight neutrality and very low risk of hypoglycaemia,” he added.

Growing problem

There is certainly an urgent need for new approaches and novel treatments to help battle diabetes. As the group points out, there are nearly 150,000 people in Scotland with type 2 diabetes and, despite current therapies available on the market, around two-thirds of adults with the condition in the UK are still not managing to control their blood sugar levels.

Furthermore, aside from the obvious detriment to a patient’s health, inadequate control of blood sugar presents a substantial economic burden too; it is estimated that diabetes costs the National Health Service an incredible £150,000 every hour, with the majority of this spent on treating complications of the disease.

Januvia looks poised to become one of MSD’s star performers. Earlier this month, the was honoured with the 2007 award for Best Pharmaceutical Agent at the Prix Galien USA Awards, beating off stiff competition from 19 other compounds, and analysts are predicting annual peak sales up to $2 billion.