B29N(epsilon)-omega-carboxypentadecanoyl-gamma-L-glutamyl desB30 human insulin
Insulin degludec is a ultralong-acting basal insulin analogue being developed by Novo Nordisk under the brand name Tresiba. It is injected subcutaneously three-times a week to help control the blood sugar level of those with diabetes. It has a duration of action that lasts up to 40 hours, unlike the 18 to 26 hours provided by current marketed long-acting insulins such as insulin glargine and insulin detemir.
Insulin degludec is a modified insulin that has one single amino acid deleted in comparison to human insulin, and is conjugated to hexadecanedioic acid via gamma-L-glutamyl spacer at the amino acid lysine at position B29.
MARCH 05, 2013
Patients with diabetes in the UK can now get access to a new treatment option following the roll out of Novo Nordisk’s ultra-long-acting insulin Tresiba in the country, marking its first launch in Europe.
Tresiba (insulin degludec) is a once-daily basal insulin which, conveniently, can be administered at any time of the day and, thereby, is the first to offer diabetics flexibility in the timing of taking insulin, according to the firm.
The European Commission issued a green light for the drug – as well as sister product Ryzodeg (insulin degludec/insulin aspart) – for the treatment of diabetes in adults back in January.
Approval came on the back of studies comparing Tresiba to Sanofi’s blockbuster Lantus (insulin glargine), in which Novo’s drug demonstrated a significantly lower risk of overall and nocturnal hypoglycaemia, which is particularly important as patients are less aware of the symptoms, while successfully achieving equivalent reductions in HbA1c.
In fact, clinical data showed a 25% reduction in nocturnal hypoglycaemia for patients with type I diabetes taking Tresiba, while for insulin-naiive patients with Type II diabetes there was a 36% reduction compared to Lantus, the company said, although noting hypoglycaemia is still the most common side effect linked with its drug.
“With our current insulin treatments, it is important for people with diabetes to take their long-acting insulin at around the same time each day. However, the pharmacokinetics of insulin degludec mean that, on occasions when this is not possible, people with diabetes can alter the time they take their insulin without compromising their diabetes control or putting themselves at increased risk of hypoglycaemia,” commented Professor Richard Holt, Professor in Diabetes and Endocrinology at the University of Southampton.
“Good control of diabetes is essential to reduce the risk of long-term complications, so flexibility, when needed, is important,” he added.
In addition, its associated cut in the risk of nocturnal hypoglycaemia could give the drug another competitive edge, given that almost 50% of severe hypoglycaemic episodes – which have a significant impact not only on the patient but on the economy – occur at night.
The estimated UK cost for severe hypoglycaemia hit £30.4 million and £41.8 million for moderate hypoglycaemia in 2010/11, and each severe hypoglycaemic episode involving hospitalisation costs the NHS an estimated £2,153 per person.
The drug does come with a weighty price-tag, costing £72.00 per pack of 5 x 3 ml U100 FlexTouch pens, compared to the £41.50 per pack (5 x 3ml pre-filled pens) of Lantus. But a spokesperson for Novo stressed to PharmaTimes UK News that its price “reflects the clinical benefits and innovation that insulin degludec brings to patients”.
The National Institute for Health and Clinical Excellence will include Tresba its updated NICE Clinical Guidelines on diabetes, which are expected in 2014, the spokesperson confirmed.
Last month Novo was dealt a huge blow when US regulators knocked back Tresiba, after being reluctant to approve the drug without additional data on its cardiovascular effects.
The move came as somewhat of a surprise, given that advisers to the US Food and Drug Administration actually supported its approval, albeit with the proviso that a post-marketing cardiovascular outcomes trial be carried out.