Toujeo insulin gets Scottish go ahead

Sanofi’s Toujeo® (Insulin glargine 300 units/mL) has been approved for use in Scotland, the pharmaceutical company has announced.

The Scottish Medicines Consortium (SMC) has approved the long-acting, once-daily basal insulin treatment, for restricted use in adults with type 1 and type 2 diabetes.

Insulin glargine 300 units/mL is indicated for the treatment of diabetes in adults and is a concentrated formulation of the glargine molecule found in Lantus (insulin glargine 100 units/mL).

One in 20 people in Scotland have diabetes, a total of a quarter of a million people.

Overall in the UK, over two thirds of adults treated with insulin do not reach the National Institute for Health and Care Excellence (NICE) target for blood glucose control (HbA1c ≤ 7.5 per cent), increasing their risk of potentially avoidable complications such as amputation, blindness and renal disease.

Many clinicians cite concern of hypoglycaemia as a reason for not managing blood glucose more aggressively – three quarters (75.5 per cent) of specialists would be more aggressive in treating diabetes if there was no concern about hypoglycaemia.

‘Hypoglycaemia fear’

For patients, concern over hypoglycaemia may cause them to modify their insulin dose – four out of 10 people with type 2 diabetes reduce their insulin dose after an episode of mild hypoglycaemia and six out of 10 after a severe hypoglycaemic episode.

Dr Karen Adamson, Consultant Diabetologist at NHS Lothian, said: “This is good news that doctors in Scotland have access to a new basal insulin treatment option for their patients, especially those who are not currently reaching optimal blood glucose control.

The approval of insulin glargine 300 units/mL in Scotland is a significant milestone for Sanofi

“The fear of hypoglycaemia can prevent some patients administering appropriate doses of their insulin which can often lead to poor blood glucose control. It is critical that people with diabetes are able to manage their blood glucose, in order to avoid an increased risk of long-term complications.”

Results from clinical trials evaluating the efficacy and tolerability of insulin glargine 300 units/mL compared to insulin glargine 100 units/mL demonstrated a similar blood glucose (HbA1c) reduction with a lower incidence of confirmed hypoglycaemia in patients with type 2 diabetes on insulin glargine 300 units/mL compared to those on insulin glargine 100 units/mL.

In patients with type 1 diabetes, trials demonstrated similar blood glucose reduction but showed no difference in confirmed hypoglycaemia.

Dr David Williams, Medical Director for Sanofi UK, said: “The approval of insulin glargine 300 units/mL in Scotland is a significant milestone for Sanofi as we expand our portfolio of medicines for patients with both type 1 and type 2 diabetes and reinforces our commitment to continue improving the quality of diabetes care.”

The European Medicines Agency (EMA) licensed insulin glargine 300 units/mL in February 2015. It has also been licensed by the US Food and Drug Administration (FDA) and is under review by other regulatory authorities around the world.

The European licence was based on an assessment of the results from the EDITION clinical trial programme, which evaluated the efficacy and safety of insulin glargine 300 units/mL compared to insulin glargine 100 units/mL in over 3,500 people with diabetes.

Insulin glargine 300 units/mL is a more concentrated formulation of the insulin glargine molecule, the active ingredient of the basal insulin therapy Lantus.