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Remogliflozin: the new low cost SGLT-2 inhibitor for type 2 diabetes mellitus

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Abstract

SGLT-2 inhibitors have recently emerged as an important class of oral drugs for treatment of type 2 diabetes mellitus, especially in patients with cardiovascular or renal impairment, recommended in all recent treatment guidelines. They have additional advantages of weight and blood pressure reduction but also pose problems like genitourinary infections. These drugs generally have a high cost making affordability a major consideration in their prescription in developing countries like India. A new molecule remogliflozin has been approved in India in 2019 after a phase 3 trial proved its efficacy and safety in comparison to dapagliflozin. This drug has been priced substantially lower than other SGLT-2 inhibitors, and despite the disadvantage of twice daily administration, it potentially reduces treatment cost to less than half compared to other molecules of this class. With a good tolerability profile on the basis of available safety data till date, remogliflozin could be a useful alternative for providing SGLT-2 inhibitor therapy in a country like India where out of pocket expenses for drug acquisition matter significantly for the general population. However, long term safety and efficacy data especially on cardiovascular and renal outcomes are currently lacking for the drug.

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References

  1. American Diabetes Association. 9 Pharmacologic approaches to glycemic treatment: standards of medical care in diabetes—2020. Diabetes Care. 2020;43:S98–110.

    Article  Google Scholar 

  2. Indian Council of Medical Research. ICMR Guidelines for Management of Type 2 Diabetes 2018. https://medibulletin.com/wpcontent/uploads/2018/05/ICMR.diabetesGuidelines.2018.pdf. Accessed 26 Nov 2019.

  3. Cosentino F, Grant PJ, Aboyans V, et al. 2019 ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the task force for Diabetes, pre diabetes and Cardiovascular Diseases of the European Society of Cardiology (ESC) and the European Association for the Study of Diabetes (EASD). Eur Heart J. 2020;4:255–323.

    Article  Google Scholar 

  4. Betonico CC, Titan SM, Correa-Giannella ML, et al. Management of diabetes mellitus in individuals with chronic kidney disease: therapeutic perspectives and glycemic control. Clinics. 2016;71:47–53.

    Article  Google Scholar 

  5. Central Drugs Standards Control Organisation. Approval of dapagliflozin and empagliflozin. List of approved drugs from 01-01-2015 to 31-01-2015. https://cspc.in/dic/pdf/Approved%20drugs%20In%20India%20Year%202015.pdf. Accessed 20 Dec 2019.

  6. Central Drugs Standards Control Organisation. Approval of canagliflozin. Drugs approved from 1st Jan 2014 to 31 december 2014. https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MzIyOA==. Accessed 20 Dec 2019.

  7. Remogliflozin etabonate—Avolynt/Kissei-Pharmaceutica. https://adisinsight.springer.com/drugs/800021813. Accessed 26 Nov 2019.

  8. Avolynt, Inc. Announces First Marketing Authorization and Commercial Launch of Novel SGLT2 Inhibitor Remogliflozin Etabonate for Type 2 Diabetes. https://13e7f770-4ade-43d5-8f6a-6c643672a9c0.filesusr.com/ugd/e4def4_76977eb2388d40afbcc14bf28561fe89.pdf. Accessed 28 Nov 2019.

  9. Clinical trials registry-India. CTRI /2017/07/009121. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19549&EncHid=&userName=remogliflozin. Accessed 26 Nov 2019.

  10. Clinical trials registry-India. CTRI/2017/10/010043. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=20565&EncHid=&userName=remogliflozin. Accessed 26 Nov 2019.

  11. Clinical trials registry-India. CTRI/2017/06/008887. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19284&EncHid=&userName=remogliflozin. Accessed 26th Nov 2019.

  12. Central Drugs Standards Control Organisation. List of new drugs approved in the year 2019 till date. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadApprovalNewDrugs/newdruaaopvalariol.pdf. Accessed 26 Nov 2019.

  13. IND Committee. Minutes of IND committee meeting held on 15.03.2019 at ICMR (HQ). Agenda no. 3: application for marketing authorization of remogliflozin of M/s Glenmark Pharmaceuticals. 2019. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/IND15mar19.pdf. Accessed 26 Nov 2019.

  14. Glenmark Pharma launches anti-diabetes drug Remogliflozin in India. https://economictimes.indiatimes.com/markets/stocks/news/glenmark-pharma-launches-anti-diabetes-drug-remogliflozin-in-india/articleshow/69109769.cms?from=mdr. Accessed 10 Dec 2019.

  15. Press Release. Glenmark & Torrent sign licensing agreement for co-marketing of Remogliflozin Etabonate in India. https://www.glenmarkpharma.com/sites/default/files/Glenmark-%26-Torrent-sign-licensing-agreement-for-co-marketing-of-Remogliflozin-Etabonate-in-India.pdf. Accessed 26 Nov 2019.

  16. Press Release. Glenmark receives approval for combination of Remogliflozin Etabonate and Metformin Hydrochloride for adults with type 2 diabetes in India. https://www.glenmarkpharma.com/sites/default/files/Glenmark-receives-approval-for-combination-of-Remogliflozin-Etabonate-an.pdf. Accessed 26 Nov 2019.

  17. Clinical trials registry-India. A post marketing study to evaluate safety and effectiveness of Remogliflozin and Remogliflozin-Metformin Combination in treatment of Diabetes patients. https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=36536&EncHid=&userName=remogliflozin. Accessed 26 Nov 2019.

  18. IND Committee. Minutes of IND committee meeting held on 10.06.2019 at ICMR (HQ). Agenda no. 4: Application for marketing authorization of Remogliflozin and Metformin of M/s Glenmark Pharmaceuticals. 2019. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/INDCommitteeheldonjun19.pdf. Accessed 28 Nov 2019.

  19. Dash RP, Babu RJ, Srinivas NR. Comparative pharmacokinetics of three SGLT-2 inhibitors sergliflozin, remogliflozin and ertugliflozin: an overview. Xenobiotica. 2016;47:1015–26.

    Article  Google Scholar 

  20. Fujimori Y, Katsuno K, Nakashima I, et al. Remogliflozin etabonate, in a novel category of selective low-affinity sodium glucose cotransporter (SGLT2) inhibitors, exhibits antidiabetic efficacy in rodent models. J Pharmacol Exp Ther. 2008;327:268–76.

    Article  CAS  Google Scholar 

  21. O’Connor-Semmes R, Walker S, Kapur A, et al. Pharmacokinetics and pharmacodynamics of the SGLT2 inhibitor remogliflozin etabonate in subjects with mild to moderate renal impairment. Drug MetabDispos. 2015;43:1077–83.

    Google Scholar 

  22. Sigafoos JF, Bowers GD, Castellino S, et al. Assessment of the drug interaction risk for remogliflozin etabonate, a sodium-dependent glucose cotransporter-2 inhibitor: evidence from in vitro, human mass balance, and ketoconazole interaction studies. Drug MetabDispos. 2012;40:2090–101.

    CAS  Google Scholar 

  23. Kapur A, O’Connor-Semmes R, Hussey EK, et al. First human dose escalation study with remogliflozin etabonate, a selective inhibitor of the sodium-glucose transporter 2(SGLT2), in healthy subjects and in subjects with type 2 diabetes mellitus. BMC Pharmacol Toxicol. 2013;14:1–11.

    Article  Google Scholar 

  24. Dobbins RL, O’Connor-Semmes R, Kapur A, et al. Remogliflozin etabonate, a selective inhibitor of the sodium dependent transporter 2 reduces serum glucose in type 2 diabetes mellitus patients. Diabetes ObesMetab. 2012;14:15–22.

    CAS  Google Scholar 

  25. Mudaliar S, Armstrong DA, Mavian AA, et al. Remogliflozin etabonate, a selective inhibitor of the sodium-glucose transporter 2, improves serum glucose profiles in type 1 diabetes. Diabetes Care. 2012;35:2198–200.

    Article  CAS  Google Scholar 

  26. Sykes AP, Kemp GL, Dobbins R, et al. Randomized efficacy and safety trial of once-daily remogliflozin etabonate for the treatment of type 2 diabetes. DiabetesObesMetab. 2014;98–98:101.

    Google Scholar 

  27. Sykes AP, O’Connor-Semmes R, Dobbins R, et al. Randomized trial showing efficacy and safety of twice-daily remogliflozin etabonate for the treatment of type 2 diabetes. DiabetesObesMetab. 2015;17:94–7.

    CAS  Google Scholar 

  28. Dharmalingam M, Aravind SR, Thacker H, et al. Efficacy and safety of remogliflozin etabonate, a new sodium glucose co-transporter-2 inhibitor, in patients with type 2 diabetes mellitus: a 24-week, randomized, double-blind, active-controlled trial. Drugs. 2020;80:587–600.

    Article  CAS  Google Scholar 

  29. Avolynt, Inc. Announces Positive Topline Data for Phase 2b BRID Study of SGLT2 Remogliflozin. https://13e7f770-4ade-43d5-8f6a-6c643672a9c0.filesusr.com/ugd/e4def4_f13db80522d64501810463a93434bd81.pdf. Accessed 26 Nov 2019.

  30. Mikhail N. Remogliflozin etabonate: a novel SGLT2 inhibitor for treatment of diabetes mellitus. Expert OpinInvestig Drugs. 2015;24:1–7.

    Article  Google Scholar 

  31. Donnan JR, Grandy CA, Chibrikov E, et al. Comparative safety of the sodium glucose co-transporter 2 (SGLT2) inhibitors: a systematic review and meta-analysis. BMJ Open. 2019;9:e022577.

    Article  Google Scholar 

  32. Drug Watch. SGLT2 Inhibitors Side Effects. https://www.drugwatch.com/sglt2-inhibitors/side-effects/. Accessed 26 Nov 2019.

  33. Food and Drug Administration. FDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-about-rare-occurrences-serious-infection-genital-area-sglt2-inhibitors-diabetes. Accessed 26 Nov 2019.

  34. India: DCGI Asked Manufacturers To Write Safety Warning For SGLT2 Inhibitors. https://www.mondaq.com/india/x/799006/Healthcare/DCGI+Asked+Manufacturers+To+Write+Safety+Warning+For+SGLT2+Inhibitors Accessed 26 Nov 2019.

  35. Zinman B, Wanner C, Lachin JM, et al. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015;373:211728.

    Article  Google Scholar 

  36. Neal B, Perkovic V, Mahaffey KW, et al. Canagliflozin and cardiovascular and renal events in type 2 diabetes. N Engl J Med. 2017;377:644–57.

    Article  CAS  Google Scholar 

  37. Wiviott SD, Raz I, Bonaca MP, et al. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2019;380:347–57.

    Article  CAS  Google Scholar 

  38. International Diabetes Federation. IDF Diabetes Atlas, 9th edn. Brussels, Belgium: 2019. https://www.diabetesatlas.org. Accessed 28 Nov 2019.

  39. Bhalla SS. India is middle income country now: raise the poverty line. https://indianexpress.com/article/opinion/columns/india-is-middle-income-now-raise-the-poverty-line-5239269/. Accessed 26 Nov 2019.

  40. Thakur A, Ray TK, Goel MK. Expenditure pattern on diabetes care: a community based longitudinal study in resettlement colony of East Delhi. Indian J Community Health. 2017;29:209–12.

    Google Scholar 

  41. Fernandes SD, Fernandes SDA. Economic burden of diabetes mellitus and its socio-economic impact on household expenditure in an urban slum area. Int J Res Med Sci. 2017;5:1808–13.

    Article  Google Scholar 

  42. Kumar A, Nagpal J, Bhartia A. Direct cost of ambulatory care of type 2 diabetes in the middle and high income group populace of Delhi. J Assoc Physician India. 2008;56:667–74.

    CAS  Google Scholar 

  43. Pharma may see a price war in good news for diabetics. https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/pharma-may-see-a-price-war-in-good-news-for-diabetics/articleshow/69122707.cms?from=mdr. Accessed 26 Nov 2019.

  44. Glenmark brings new diabetes drug Remogliflozin to India. https://www.thehindubusinessline.com/companies/glenmark-pharma-launches-anti-diabetes-drug-remogliflozin-in-india/article26990038.ece. Accessed 26th Nov 2019.

  45. Glenmark launches Teneligliptin—an advanced Diabetes treatment at significantly affordable cost in India. https://mdcurrent.in/press-releases/glenmark-launches-teneligliptin-an-advanced-diabetes-treatment-at-significantly-affordable-cost-in-india/. Accessed 26 Nov 2019.

  46. Pradhan mantra bhartiya jan aushadhi yojana Kendra. https://janaushadhi.gov.in/Data/pmbjp-book.pdf. Accessed 26 Nov 2019.

  47. Sharma EK. Diabetes drug price to halve as patent expires; cheaper versions expected soon. https://www.businesstoday.in/sectors/pharma/diabetes-drug-price-to-halve-as-patent-expires-cheaper-versions-expected-soon/story/391768.html. Accessed 28 Mar 2020.

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Authors and Affiliations

  1. Department of Pharmacology, All India Institute of Medical Sciences Bhopal, Bhopal, India

    Shubham Atal, Zeenat Fatima & Sadasivam Balakrishnan

  2. Department of Pharmacology, Geetanjali Medical College and Hospital, Udaipur, India

    Sakshi Singh

  3. Department of General Medicine, All India Institute of Medical Sciences Bhopal, Bhopal, India

    Rajnish Joshi

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  1. Shubham Atal
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  2. Zeenat Fatima
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Atal, S., Fatima, Z., Singh, S. et al. Remogliflozin: the new low cost SGLT-2 inhibitor for type 2 diabetes mellitus. Diabetol Int 12, 247–253 (2021). https://doi.org/10.1007/s13340-020-00472-4

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