European green light for Novo’s Tresiba
pharmafile | October 24, 2012 | News story | Sales and Marketing | EMA, Novo Nordisk, Tresiba
The European Medicines Agency has given the go-ahead for Novo Nordisk’s Tresiba, a new basal analogue insulin to treat diabetes mellitus in adults, to reach the market.
Tresiba (insulin degludec) is the first insulin approved in Europe at a higher strength than the EU-wide standard of 100 units/ml: it comes in a pre-filled pen in both 100 and 200 units/ml formulations.
It means that patients can now receive up to 160 units of insulin in one go – the maximum that can be given in a single injection of 100 units/ml is only 80 units.
This is a significant change as lifestyle and diet trends, such as sedentary working and more processed foods, mean that insulin resistance is increasing.
Patients are therefore requiring insulin injections in higher doses to achieve glycaemic control – in fact, the CHMP estimates that between 200,000 and 700,000 people in the EU need more than 80 units per injection to manage blood-sugar levels.
Novo’s diabetes franchise had sales of $8.91 billion last year (in front of Sanofi with $7.36 billion) and analysts say Tresiba could make more than $3 billion a year.
The brand is likely to put a major dent in Sanofi’s own long-acting insulin analogue Lantus (insulin glargine), the world’s biggest-selling diabetes treatment, earning $5.2 billion in 2011 – locking the two manufacturers into a battle for supremacy.
Worldwide there are now thought to be 250 million diabetics, a figure that could rise to 380 million by 2025.
The CHMP said one of its key considerations was how to minimise the risk of medication errors between the two doses.
It has tried to achieve this by only presenting the 200 units/ml strength in a pre-filled pen, having both strengths as dialled-in units, clearly differentiating the two pack designs and putting an educational programme in place.
Tresiba was due to be among the off-label or unlicensed drugs included in NICE’s new evidence summaries later this month.
Adam Hill
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