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IF YOU OR A LOVED ONE HAS TYPE 1 DIABETES (T1D),
YOU KNOW ABOUT THE CONSTANT 24/7 EFFORTS
TO STAY UNDER CONTROL WITH LIMITED SUCCESS
AND ENDURING COMPLICATIONS.

JOIN THE EFFORTS TO BRING THIS
LIFE-CHANGING MEDICATION TO THOSE
WHO NEED IT MOST. EVERY VOICE MATTERS.
THE TIME FOR ACTION IS NOW.

TO THE U.S. FOOD AND DRUG ADMINISTRATION

Support for the Approval of Sotagliflozin as a New Treatment for Glycemic Control for the 1.7 million US adults with T1D – A Therapy Already Approved in Europe and Urgently Needed Here at Home

We urgently call upon the U.S. Food and Drug Administration (FDA) and FDA Commissioner Makary to prioritize the approval of sotagliflozin—a treatment that was approved in Europe on the same data 5 years ago. Sotagliflozin offers the opportunity to achieve better glycemic control, stabilize kidney function, and reduce the rates of morbidity and mortality associated with T1D. Patients and their healthcare teams deserve the right to evaluate the risk-benefit ratio and to choose the best course of treatment—one that could dramatically change the trajectory of this disease.

This petition represents the voices of T1D patients, families, healthcare providers, and advocates who are eager for innovative and effective options to manage this life-altering condition.

BACKGROUND ON T1D:

The FDA has approved many oral agents for Type 2 diabetes but has never approved any for T1D patients, who, since life-saving insulin was discovered in the 1920’s, have had to rely only on a strict regimen of insulin therapy, lifestyle management, and constant monitoring. Despite advances in treatment and motivation to live well with diabetes, the majority patients struggle to maintain adequate blood glucose levels (only 21% achieve an A1C less than 7%), facing risks of both hyperglycemia and hypoglycemia, as well as the risk for long-term complications.

The burden to achieve adequate control using current treatment options on individuals and families, along with the physical and psychological impacts, can be overwhelming and lead to
diabetes burnout.

WHY SOTAGLIFLOZIN MATTERS:

1. Improved Quality of Life: Sotagliflozin offers potential benefits that can significantly ease the daily burden of managing T1D, including better glucose control and reduced risk of hypoglycemia and chronic kidney disease (CKD).
2. Reduction of Long-Term Complications: Early and effective treatments like sotagliflozin could potentially reduce the risk of complications affecting eyes, kidneys, heart, and nerves, benefiting both patients and the healthcare system. (#MAHA)
3. Broad Support from the T1D Community: The T1D community – comprising patients and their health care teams – balances risks and benefits every day, and their support for sotagliflozin reflects the community’s need for more advanced and effective therapies, as well as its ability to manage the risks associated with sotagliflozin, including diabetic ketoacidosis (DKA). (#T1DTreatmentNow)

THANK YOU FOR YOUR ATTENTION
TO THIS URGENT MATTER

SHOW YOUR SUPPORT FOR PEOPLE WITH
T1D BY SIGNING ON TO THE PETITION
AT https://chng.it/GN9HLDZPcd

Additionally, contact the FDA Commissioner to support approval:
FDACommissioner@fda.hhs.gov
The Honorable Martin A. Makary, MD
Commissioner of Food and Drugs
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993