FDA Rejects Sotagliflozin for Type 1 Diabetes


In a decision that wasn’t seen entirely as a surprise, the U.S. Food and Drug Administration (FDA) has rejected the current drug application for sotagliflozin, a drug intended to be used as an adjunct to insulin[1] for Type 1 diabetes[2] that was to be marketed as Zynquista.

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In a press release[3] on March 22, Sanofi — one of two pharmaceutical companies backing the drug — revealed that the FDA had issued a letter explaining its reasons for not giving its approval.

An FDA committee had already split 8–8 in a vote on the drug[4] in January, indicating that many of the experts had concerns about the risks of sotagliflozin compared with its benefits.

During that committee meeting, several members had expressed concern that the increased risk of ketoacidosis[5] associated with sotagliflozin didn’t justify what they viewed as modest improvements in blood glucose[6] levels when the drug was taken along with insulin.

This decision contrasts with a European Medicines Agency committee decision on sotagliflozin, which gave the drug a positive opinion[7] on February 28. This means it will almost certainly be approved in Europe in the coming weeks or months.

Sotagliflozin is a dual SGLT1 and SGLT2 inhibitor intended for use in people with Type 1 diabetes with a body-mass index (BMI)[8] above 27 who haven’t achieved ideal blood glucose control on insulin alone.

Want to learn more about SGLT2 inhibitors? Read “Diabetes Medicine: SGLT2 Inhibitors.”[9]

Endnotes:
  1. insulin: https://www.diabetesselfmanagement.com/diabetes-resources/definitions/insulin/
  2. Type 1 diabetes: https://www.diabetesselfmanagement.com/diabetes-resources/definitions/type-1-diabetes/
  3. press release: http://www.news.sanofi.us/2019-03-22-FDA-issues-Complete-Response-Letter-for-Zynquista-TM-sotagliflozin
  4. in a vote on the drug: http://www.news.sanofi.us/2019-01-17-FDA-advisory-committee-votes-on-Zynquista-TM-sotagliflozin-as-treatment-for-adults-with-type-1-diabetes
  5. ketoacidosis: https://www.diabetesselfmanagement.com/diabetes-resources/definitions/ketoacidosis/
  6. glucose: https://www.diabetesselfmanagement.com/diabetes-resources/definitions/glucose/
  7. gave the drug a positive opinion: https://www.ema.europa.eu/en/news/new-add-treatment-insulin-treatment-certain-patients-type-1-diabetes
  8. body-mass index (BMI): https://www.diabetesselfmanagement.com/diabetes-resources/definitions/body-mass-index/
  9. “Diabetes Medicine: SGLT2 Inhibitors.”: https://www.diabetesselfmanagement.com/blog/diabetes-medicine-sglt2-inhibitors/

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