Novo Nordisk’s hopes of maintaining its leadership of the diabetes market have been boosted by new data on its insulin products Tresiba and Xultophy.
The Danish company has unveiled phase III trial results showing that a concentrated, once-daily dose of Tresiba (insulin degludec) is as effective as Sanofi’s twice-daily Lantus (insulin glargine) at controlling blood sugar, and less likely to cause low blood sugar episodes (hypoglycaemia).
The high-strength dose has twice the insulin payload of Lantus and will reduce the burden of injections for diabetics who require higher levels of the drug to control blood sugar.
Meanwhile, the results of the DUAL trial of recently-launched combination product Xultophy – which combines insulin degludec with Novo’s GLP-1 agonist Victoza (liraglutide) – showed greater improvements in treatment-related satisfaction and patient-reported physical health compared to Lantus.
The two studies were presented at the European Association for the Study of Diabetes (EASD) annual meeting in Stockholm, Sweden, yesterday.
Novo recently supplanted Sanofi as the world’s biggest diabetes drug manufacturer, and the new data come as it is hoping to secure US approval for Tresiba after a delay of two years caused by an FDA request for additional data on its cardiovascular safety.
Armed with interim data from the DEVOTE cardiovascular outcomes trial, the company re-submitted its application for Tresiba earlier this year and is expecting to hear from the agency within the next few weeks.
The two studies pit both of Novo’s new insulin drugs against the $8bn-a-year Lantus, but in the marketplace they will compete more closely with Sanofi’s long-acting follow-up Toujeo and insulin/GLP-1 agonist combination LixiLan (insulin glargine and lixisenatide) which is due to be filed for approval by the end of the year in the US.
With Eli Lilly and Boehringer Ingelheim’s biosimilar Lantus product Abasaglar now available in its first European countries, the basal insulin market looks set to become a two-tier segment, split between the newer, improved brands and older, cheaper products.
The big question for Novo and Sanofi is whether they can persuade prescribers that the new drugs are worth the money.
On that score, analysts seem to think they are onto a winner, albeit at not quite the scale of Lantus itself – Tresiba is tipped to make upwards of $2bn at peak, with Xultophy potentially adding another $1bn, while Toujeo and LixiLan are both predicted to become $1bn-plus brands.