EU approval for Novo Nordisk diabetes drugs
pharmafile | January 24, 2013 | News story | Sales and Marketing | Novo Nordisk, Ryzodeg, Tresiba
Novo Nordisk is celebrating after European regulators approved two of its drugs for the treatment of adults with diabetes.
The Danish manufacturer will launch Tresiba (insulin degludec) in the EU now and expects to launch Ryzodeg (insulin degludec/insulin aspart) in around a year’s time.
Both products received the green light from the CHMP last October and will be available in Novo’s FlexTouch prefilled insulin pen.
Tresiba is the first insulin approved in Europe at a higher strength than the EU-wide standard of 100 units/ml and analysts say it could make more than $3 billion a year.
Available in both 100 and 200 units/ml formulations, it means (since the maximum that can be given in a single injection of 100 units/ml is 80 units) patients will be able to receive up to 160 units of insulin in one go.
This is a significant change: patients increasingly require insulin in higher doses to achieve glycaemic control because lifestyle and diet trends, such as sedentary working and more processed foods, mean that insulin resistance is increasing.
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.
Ryzodeg contains the new-generation basal insulin degludec with a bolus boost of insulin aspart in a soluble formulation which can be administered once or twice-daily with meals.
In studies comparing it to Novo’s own insulin NovoMix, Ryzodeg demonstrated a significantly lower risk of overall and nocturnal hypoglycaemia while achieving the same reductions in HbA1c.
Novo’s diabetes franchise had sales of $8.91 billion in 2011, ahead of Sanofi with $7.36 billion, with the two manufacturers locked into a battle for supremacy.
Tresiba 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.
Tresiba and Ryzodeg are also currently under review in the US.
There are now thought to be 250 million diabetes sufferers in the world, a figure that could rise to 380 million by 2025.
Adam Hill
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