Sanofi trumpets new IGlarLixi data after regulatory delay

Sanofi is highlighting new data for its IGlarLixi combination drug for diabetes showing it is more effective at controlling mealtime blood glucose than its Lantus blockbuster.

The French pharma group has reported a new analysis of phase III results showing that IGlarLixi - which combines the active ingredients in Lantus (insulin glargine) with Sanofi's GLP-1 agonist Lyxumia (lixisenatide) - helped more patients with type 2 diabetes reach post-prandial glucose targets than Lantus.

"Controlling mealtime blood sugar is an important element of maintaining overall blood sugar control, which plays a role in helping patients treat their diabetes," commented Josep Vidal of the Hospital Clinic of Barcelona, who presented the results at the European Association for the Study of Diabetes (EASD) meeting in Munich yesterday.

Prior results from the LixiLan-L trial have shown that the combination is more effective than Lantus in controlling haemoglobin A1c levels, a biomarker for glucose control over time.

Traditionally, the primary goal of blood sugar (glycaemic) control in the treatment of diabetes was to normalise fasting plasma glucose levels. However in recent years it has become established that postprandial plasma glucose levels also play an important role in overall glycaemic control.

Sharp increases in blood glucose after meals can contribute to insulin resistance, decrease insulin production and according to some studies increase the risk of vascular complications.

The data is a minor boost for Sanofi, which is playing catch-up in a race to market with diabetes rival Novo Nordisk to bring a combined insulin/GLP-1 agonist product to the US market.

Novo Nordisk's IDeglira/Xultophy (insulin degludec/liraglutide) is already on the market in Europe, but Sanofi had been hoping to get IGlarLixi to market in the US first with the help of a priority review voucher it bought for $245m.

The FDA scuppered those plans last month by announcing a delay of up to three months in its review of IGlarLixi, setting a decision date to the end of November. Novo Nordisk is due to hear a verdict on Xultophy later this month.