A European regulator has recommended the approval of Novo Nordisk‘s Tresiba, a new basal analogue insulin for the treatment of diabetes mellitus in adults.
Marketing authorisation of the treatment could mark the first insulin approved in Europe at a higher strength than the EU-wide standard of 100 units/ml.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) backed the approval of a 200 units/ml insulin, allowing doses up to 160 units in a single injection.
Weight gain, less healthy diets and less physical activity often mean that patients may experience higher levels of insulin resistance and require insulin injections in higher doses to achieve glycaemic control, the agency said.
It is estimated that up to 700,000 diabetes patients in the EU require insulin injections of over 80 units per injection to manage their blood-sugar levels.
To minimise the risk of over- and under-dosing when using a 200 units/ml product, patients and healthcare professionals were consulted during CHMP’s evaluation of Tresiba, especially on the design of the pre-filled pen, pack design and product information.
But, there was consensus among patients, healthcare professionals, experts and the CHMP that the introduction of a new insulin strength will require careful preparation to introduce it safely on the market.
The advisory panel of the United States Food and Drug Administration is expected to publish its recommendation of a Tresiba approval on November 8.
Image: Around 700,000 diabetes patients in the EU require insulin injections of over 80 units per injection. Photo: Courtesy of FreeDigitalPhotos.net.