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

  1. ↑ "Lixisenatide/insulin glargine". AdisInsight. Retrieved 23 September 2016.
  2. ↑ Christensen, M; Knop, FK; Holst, JJ; Vilsboll, T (2009). "Lixisenatide, a novel GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus". IDrugs : the investigational drugs journal. 12 (8): 503–13. PMID 19629885.
  3. ↑ Terry, Mark (November 5, 2015). "In Attempt to Bolster Sagging Diabetes Revenue Sanofi Inks Deal with Hanmi Pharma Worth 4 2 Billion". Biospace.
  4. ↑ "Lyxumia 10 micrograms solution for injection - Summary of Product Characteristics (SPC)". UK Electronic Medicines Compendium. 2 May 2016. Retrieved 21 September 2016.
  5. ↑ "Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA". Drugs.com/PR Newsire. 19 February 2013.
  6. ↑ Hughes, Sue (July 3, 2008). "FDA Advisory Committee Recommends Cardiovascular Safety Studies for Diabetes Drugs". Medscape.
  7. ↑ Nainggolan, Lisa (September 12, 2013). "Sanofi Withdraws US NDA for GLP-1 Agonist Lixisenatide". Medscape.
  8. ↑ Humphreys, Andrew (December 1, 2013). "Reaching Epic Proportions 2013". PharmaLive.
  9. ↑ Taylor, Phil (September 30, 2015). "Sanofi's lixisenatide is back under FDA review". PM Live.
  10. ↑ "FDA approves Adlyxin to treat type 2 diabetes". FDA. 28 July 2016. Retrieved 28 July 2016.
  11. 1 2 "Zealand extends Lixisenatide licence with S-A". PMLive. June 8, 2010.
  12. ↑ Carroll, John (May 25, 2016). "FDA panel backs 2nd diabetes combo, endorses Sanofi's iGlarLixi". FierceBiotech.
  13. 1 2 Farooq, Raheel (May 24, 2016). "Sanofi SA (ADR) and Diabetes: Things Are Not Working Out". Business Finance News.
  14. ↑ "FDA Briefing Document Endocrinologic and Metabolic Drugs Advisory Committee Meeting" (PDF). FDA. May 25, 2016.
  15. ↑ Nainggolan, Lisa (August 25, 2016). "Sanofi's GLP-1/Insulin Combo LixiLan Faces 3-Month Delay in US". Medscape.
  16. ↑ "Summary Minutes of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting" (PDF). FDA. May 25, 2016.
  17. ↑ Staton, Tracy (August 21, 2016). "With FDA delay, Sanofi loses head start in diabetes combo-med rivalry with Novo". FiercePharma.



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