Breakthrough T1D, formerly JDRF, is disappointed to learn that a U.S. Food and Drug Administration (FDA) advisory committee did not recommend approval of sotagliflozin for people with T1D and chronic kidney disease.
There remains a deep unmet need for therapies that improve health outcomes and quality of life for those with T1D, especially for those who live with T1D and chronic kidney disease. Breakthrough T1D believes in sotagliflozin’s potential as an adjunctive therapy that could improve the lives of people with T1D and chronic kidney disease and is currently funding a phase 3 clinical trial to further test its effectiveness for these individuals.
As the formal review process moves forward, Breakthrough T1D will continue to invest in research to develop therapies for kidney disease in T1D that can help people live longer and healthier lives.
Breakthrough T1D Public Comments to FDA Endocrinologic and Metabolic Drugs Advisory Committee Meeting to Discuss Sotagliflozin
Good afternoon, my name is Dr. Sanjoy Dutta. I’m the Chief Scientific Officer at Breakthrough T1D, formerly JDRF, the leading global type 1 diabetes research and advocacy organization.
Breakthrough T1D has co-funded several clinical trials of sotagliflozin in T1D. The grant terms of some studies include the potential for Breakthrough T1D to receive a portion of the net royalties to fund additional research. Some people believe improvements in diabetes care have progressed such that little risk should be tolerated when considering new therapies. We disagree.
Insulin is not a cure and the physical, cognitive, and emotional burdens of managing T1D with insulin are still not adequately recognized. Recent data show only 26% of individuals with T1D in the United States are able to achieve the recommended HbA1c target of less than 7% and people with T1D die 11 years earlier than their non-diabetic counterparts.
Novel therapies that improve glycemic control, clinical outcomes, and quality of life for those with T1D are desperately needed, especially for those who also live with chronic kidney disease.
The evidence shows that the addition of sotagliflozin results in improved A1c, as well as reduced hypoglycemia and increased time-in-range, both glycemic outcomes that are well established as important and clinically meaningful to clinicians and patients. It is also reasonable to expect the renal benefits of sotagliflozin seen in type 2 diabetes would be seen in T1D, and we are encouraged by data demonstrating sotagliflozin’s benefits on markers of kidney function in T1D.
While therapies like sotagliflozin are increasingly available for individuals with type 2 diabetes, people with T1D are being left behind and are consistently excluded from studies. Breakthrough T1D strongly believes in the potential of sotagliflozin as an adjunctive to insulin, especially for those with CKD, and continues to support research to this end, with several studies ongoing.
As we have heard today, a key consideration for the safe use of sotagliflozin is the risk of diabetic ketoacidosis. DKA is a concern for all individuals with T1D, and vigilance for DKA is a routine aspect of living with T1D. DKA risk has been shown to increase with use of SGLT inhibitors, and this requires appropriate monitoring and mitigation strategies.
Experts have convened to consider this risk, and international consensus has been published with agreed upon strategies to mitigate the risks of DKA for individuals with T1D using SGLT inhibitors.
We ask FDA and the committee to carefully consider the risks of living with T1D today, even with the best available care, as they consider if the benefits of sotagliflozin outweigh the risks in those with T1D and CKD.
Thank you.
