Insulin glargine/lixisenatide

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Insulin glargine/lixisenatide
Combination of
Glucagon-like peptide-1 receptor agonist
Clinical data
Trade namesSoliqua, Suliqua, others
Other namesHOE901/AVE0010
AHFS/Drugs.comProfessional Drug Facts
Pregnancy
category
Subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
KEGG

Insulin glargine/lixisenatide, sold under the brand name Soliqua among others, is a

fixed-dose combination medication that combines insulin glargine and lixisenatide and is used to treat diabetes
.

The most common side effects include hypoglycemia (low blood glucose), diarrhea, vomiting and nausea (feeling sick).[5]

Insulin glargine/lixisenatide was approved for medical use in the United States in November 2016, and in the European Union in January 2017.[4][5]

Medical uses

Insulin glargine/lixisenatide is approved as a prescription for adults with

HbA1C levels remain above target (7% for most type 2 people with diabetes) following use of basal insulin.[7]

The use of insulin glargine/lixisenatide and lixisenatide-containing products is not recommended for use while pregnant.

Soliqua during breastfeeding.[4]

Adverse effects

Prior to the approval of insulin glargine/lixisenatide, two studies were conducted to evaluate the safety of the formulation.

nasopharyngitis, diarrhea, upper respiratory tract infections, and headache. In Study A (N=469), symptoms of hypoglycemia were recorded in 25.6% of people with zero cases of severe symptomatic hypoglycemia. Study B (N=365) had a 40% incidence of hypoglycemic events with 1.1% incidence of severe hypoglycemia requiring assistance.[4]

Interactions

Lixisenatide and other

antibiotics are among other drugs that are affected by this action of lixisenatide.[8]

History

Lixisenatide is a

Avandia)[14] Sanofi decided to withdraw the NDA and wait for the results of a Phase III study that was scheduled to be completed in 2015.[15][16] 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.[17] Lixisenatide received FDA approval on 28 July 2016.[18]

In 2010,

Victoza.[20] Sanofi's application was considered by the same Endocrinologic and Metabolic Drugs Advisory FDA Committee that was considering lixisenatide as a single agent.[21][22] 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.[21][23][24] 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.[25] In November 2016, the FDA approved Sanofi's Soliqua formulation (insulin glargine 100 units/mL and lixisenatide 33 mcg/mL).[6] Soliqua became available in American pharmacies in January 2017.[26]

Society and culture

Economics

Following the US approval of Soliqua, Sanofi made a US$25 million milestone payment to Zealand.[27] Zealand may receive additional payments up to US$110 million along with receiving royalties on global sales. Royalties paid to Zealand for Soliqua are based on a fixed low double-digit percentage of net sales.[27]

In January 2017, Sanofi announced that the wholesale acquisition cost (WAC) of a 3 ml pen of Soliqua is US$127.[26] At the average dose used in clinical trials, this amounts to US$19.90 per day.[26]

According to Sanofi's Half-Year Financial Report, the net sales of Soliqua reached €9 million in the first six months of availability in the United States.[28]

Brand names

Insulin glargine/lixisenatide was called HOE901/AVE0010 during development and, as of October 2017, has been marketed under the brand names iGlarLixi, Lantus/Lyxumia, LixiLan, and Soliqua.[29]

References

  1. ^ "Insulin glargine / lixisenatide (Soliqua) Use During Pregnancy". Drugs.com. 21 May 2020. Retrieved 27 November 2020.
  2. ^ "Regulatory Decision Summary - Soliqua". Health Canada. 23 October 2014. Retrieved 7 June 2022.
  3. ^ "Drug and medical device highlights 2018: Helping you maintain and improve your health". Health Canada. 14 October 2020. Retrieved 17 April 2024.
  4. ^ a b c d e f g "Soliqua 100/33- insulin glargine and lixisenatide injection, solution". DailyMed. 15 July 2020. Retrieved 27 November 2020.
  5. ^ a b c "Suliqua EPAR". European Medicines Agency (EMA). Retrieved 10 September 2020.
  6. ^ a b "Sanofi Receives FDA Approval of Soliqua 100/33, for the Treatment of Adults with Type 2 Diabetes". Sanofi. 21 November 2016. Archived from the original on 18 July 2017. Retrieved 31 October 2017.
  7. ^ "American Diabetes Association Standards of Medical Care in Diabetes - 2017" (PDF). The Journal of Clinical and Applied Research and Education: Diabetes Care. 40 (1): 67. January 2017.
  8. ^ a b Highlights of Prescribing Information: Adlyxin (PDF). FDA. July 2016. pp. 7–8.
  9. ^ "Soliqua 100/33". Drugs.com.
  10. PMID 19629885
    .
  11. ^ Terry M (5 November 2015). "In Attempt to Bolster Sagging Diabetes Revenue Sanofi Inks Deal with Hanmi Pharma Worth 4 2 Billion". Biospace.
  12. ^ "Lyxumia 10 micrograms solution for injection - Summary of Product Characteristics (SPC)". UK Electronic Medicines Compendium. 2 May 2016. Archived from the original on 23 September 2016. Retrieved 21 September 2016.
  13. ^ "Sanofi New Drug Application for Lixisenatide Accepted for Review by FDA". Drugs.com/PR Newsire. 19 February 2013.
  14. ^ Hughes S (3 July 2008). "FDA Advisory Committee Recommends Cardiovascular Safety Studies for Diabetes Drugs". Medscape.
  15. ^ Nainggolan L (12 September 2013). "Sanofi Withdraws US NDA for GLP-1 Agonist Lixisenatide". Medscape.
  16. ^ Humphreys A (1 December 2013). "Reaching Epic Proportions 2013". PharmaLive.
  17. ^ Taylor P (30 September 2015). "Sanofi's lixisenatide is back under FDA review". PM Live.
  18. ^ "FDA approves Adlyxin to treat type 2 diabetes". FDA. 28 July 2016. Retrieved 28 July 2016.
  19. ^ a b "Zealand extends Lixisenatide licence with S-A". PMLive. 8 June 2010.
  20. ^ Carroll J (25 May 2016). "FDA panel backs 2nd diabetes combo, endorses Sanofi's iGlarLixi". FierceBiotech.
  21. ^ a b Farooq R (24 May 2016). "Sanofi SA (ADR) and Diabetes: Things Are Not Working Out". Business Finance News. Archived from the original on 23 September 2016. Retrieved 22 September 2016.
  22. ^ "FDA Briefing Document Endocrinologic and Metabolic Drugs Advisory Committee Meeting" (PDF). FDA. 25 May 2016.
  23. ^ Nainggolan L (25 August 2016). "Sanofi's GLP-1/Insulin Combo LixiLan Faces 3-Month Delay in US". Medscape.
  24. ^ "Summary Minutes of the Endocrinologic and Metabolic Drugs Advisory Committee Meeting" (PDF). FDA. 25 May 2016.
  25. ^ Staton T (21 August 2016). "With FDA delay, Sanofi loses head start in diabetes combo-med rivalry with Novo". FiercePharma.
  26. ^ a b c "Sanofi Announces Soliqua 100/33 Now Available in the U.S." Sanofi. 4 January 2017.
  27. ^ a b "Zealand reports that Sanofi announces Soliqua 100/33 now available in the U.S" (Press release). Zealand Pharma. 4 January 2017 – via GlobeNewswire.
  28. ^ Half-Year Financial Report (PDF) (2017 ed.). Sanofi. 31 July 2017. p. 50. Archived from the original (PDF) on 7 November 2017. Retrieved 1 November 2017.
  29. ^ "Lixisenatide/insulin glargine". AdisInsight. Retrieved 23 September 2016.
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