Novo Nordisk has mounted its European challenge to Sanofi’s Lantus with the launch of its insulin degludec Tresiba in the UK and Denmark ahead of a wider regional launch.
Danish pharma company Novo will be hoping that the benefits of Tresiba, which include a more flexible dosing schedule and reduced risk of hypoglycaemia, will give the product an edge over rival insulin Lantus (insulin glargine), which currently dominates the long-acting basal insulin market.
Speaking at the UK launch, Professor Melanie Davis of the University of Leicester discussed data from clinical trials comparing Tresiba to Lantus, both of which are once-daily injections to help lower glucose levels in people with either type 1 or type 2 diabetes.
She described how patients taking Tresiba were encouraged to administer the insulin at an irregular time each day, which meant a daily injection could either be given as shortly as 8 hours or as long as 40 hours after the previous dose, while patients taking Lantus injected the insulin at a set time each day in accordance with its recommendation.
She said: “If you use that sort of regimen compared to glargine given at the recommended dose, there was equal reduction HbA1c, so it does give patients much more flexibility in the timing of their injection.”
These results were achieved in combination with a reduction in events of hypoglycaemia – a side effect of insulin use that occurs when glucose levels fall too low, leading to symptoms, such as anxiety, blurred vision, difficulty in concentration, confusion and even seizure or coma in severe cases.
This benefit was most strongly seen in nocturnal hypoglycaemia, which occurs when someone is asleep. Trials demonstrated that in people with type 1 diabetes, there was a 40 per cent reduction in nocturnal hypoglycaemia in people taking Tresiba compared to Lantus, while in type 2 diabetics incidents fell by 25 per cent.
Professor Tony Barnett of the University of Birmingham explained that a reduction in the incidents of hypoglycaemia was a benefit not only for patients, but also for healthcare systems due to the potential for improved adherence and resulting reduction in costs to treat complications.
Referencing the multinational GAPP survey – a Novo-backed poll of doctors and patients about their attitudes to diabetes therapies – Prof Barnett said UK results demonstrated that fear of hypoglycaemia affected patient’s use of insulin, with a quarter of UK patients admitting to not being fully adherent with their therapy, while 16 per cent said they had missed doses altogether.
Such a lack of adherence has damaging consequences, according to Prof Barnett, with resulting complications contributing to the rising cost of diabetes care for healthcare systems, including the £10bn+ a year spent by the NHS.
“Diabetes in the UK is huge and increasing,” he said. “It has the potential to break the budget of the NHS and perhaps break our economy altogether.”
At a cost of about £2 per day in the UK, Novo will be hoping the NHS sees Tresiba as a more cost-effective option overall, with the company commenting that National Institute for Health and Clinical Excellence (NICE) has already said that Tresiba will be included in the next update of its type 2 diabetes guidance.
One issue that may impact the uptake of Tresiba in the UK is the recent decision by the US FDA to delay its recommendation of the product pending further data about its cardiovascular safety.
Novo’s medical director Dr Anders Toft said the company was discussing the decision with the FDA and pointed out the FDA’s request had “no influence on the licence in Europe and Japan”.
Prof Davies provided a clinician’s perspective: “It seems slightly strange that two authorities can look at the same information and come up with slightly different conclusions, but that’s happened a number of times quite recently.
“I don’t think there’s anything to be overly concerned about [with Tresiba’s cardiovascular safety].”
It was a point of view backed by Prof Barett, who commented that the FDA has become “increasingly sensitised” to cardiovascular data following the controversy over GlaxoSmithKline’s Avandia (rosiglitzone), which in 2011 was withdrawn in Europe and had its licence limited in the US due to safety issues.
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