Insulin glargine/lixisenatide

Insulin glargine/lixisenatide (trade name LixiLan, iGlarLixi)^[1] is a combination drug under development for treatment of diabetes between 2011 and 2016. It combines insulin glargine and lixisenatide.

History

Lixisenatide is a GLP-1 receptor agonist that was created by Zealand Pharma A/S of Denmark;^[2] in 2003 Zealand licensed it to Sanofi which developed the drug.^[3] Lixisenatide was approved by the European Commission on February 1, 2013.^[4] Sanofi submitted an NDA in the US, which was accepted for review by the US FDA in February 2013^[5] but after discussions with the FDA about the cardiovascular safety data included in the package (starting in 2008, the FDA had required stronger CV safety data for new anti-diabetes drugs, following the controversy around the risks of Avandia)^[6] Sanofi decided to withdraw the NDA and wait for the results of a Phase III study that was scheduled to be completed in 2015.^[7][8] Sanofi resubmitted the application which the FDA accepted in September 2015, by which time Sanofi had lost the lead in the field of anti-diabetic drugs to Novo Nordisk.^[9] Lixisenatide received FDA approval on July 28, 2016.^[10]

In 2010, Sanofi extended a license agreement it had with Zealand for lixisenatide to allow Sanofi to combine it with insulin glargine, which was Sanofi's best selling drug at the time, with sales of around €3 billion in 2009.^[11] Sanofi planned to start the Phase III trial that year.^[11] Sanofi submitted the new drug application in December 2015 for the combination and spent a $245M priority voucher to gain a faster review, to try to outrace Novo Nordisk’s Xultophy, a similar combination drug of Novo's insulin Tresiba and Novo's GLP-1 agonist Victoza.^[12] Sanofi's application was considered by the same Endocrinologic and Metabolic Drugs Advisory FDA Committee that was considering lixisenatide as a single agent.^[13][14] In May 2016 by a vote of 12-2, with several members of the committee expressing reservations about Sanofi's plans to offer two pens with different ratios of insulin glargine and lixisenatide - one for people who had never taken insulin before and one for people who had; there was also concern about how to handle dosing when switching people from a single drug regimen to the combination drug.^[13][15][16] In August 2016 the FDA told Sanofi that it was delaying a final decision for three months, and asked Sanofi for more data on how people used the delivery devices.^[17]

References