Sanofi: FDA Advisory Committee Votes on Oral Anti-diabetic Drug

Originally Published by Sanofi.

The Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) today voted eight to eight on the question of whether the overall benefits of Zynquista* (sotagliflozin) outweighed the risks to support approval. Sotagliflozin is an investigational oral dual SGLT1 and SGLT2 inhibitor under regulatory review as an adjunct to insulin for the treatment of adults with type 1 diabetes (T1D). While the FDA is not required to follow the committee’s vote, the agency considers the committee’s recommendations when making its decision, which is anticipated by March 22, 2019.


Sotagliflozin, developed by Sanofi and Lexicon, has the potential to be the first oral antidiabetic drug approved in the United States together with insulin therapy to improve glycemic (blood sugar) control in adults with T1D.

“We believe in the overall benefit-risk profile of sotagliflozin for adults with type 1 diabetes who lack adequate glycemic control using insulin alone,” said Rachele Berria, MD, PhD, Global Vice President and Head of Diabetes Medical Affairs, Sanofi. “We will continue to work with the FDA through its review process to hopefully bring to patients a new treatment that can help people living with type 1 diabetes control their blood sugar and address some of the challenges of insulin-only therapy.”

Sotagliflozin is an investigational oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. About 1.3 million Americans have T1D and an estimated 40,000 people will be newly diagnosed each year in the U.S., according to the American Diabetes Association.

“In clinical trials, when used in combination with insulin therapy, sotagliflozin significantly improved glycemic control without increasing hypoglycemia,” said Pablo Lapuerta, MD, Executive Vice President and Chief Medical Officer, Lexicon. “These results could not be achieved with insulin alone. Diabetic ketoacidosis is an inherent risk of type 1 diabetes and an increase was seen with sotagliflozin compared to insulin alone. We believe this can potentially be addressed with proper education and monitoring.”

The New Drug Application for sotagliflozin included data from the inTandem clinical trial program, which included three Phase 3 clinical trials assessing the safety and efficacy of sotagliflozin in approximately 3,000 adults with inadequately controlled T1D. The safety and efficacy data have not yet been fully evaluated by any regulatory authority.

Sanofi also submitted a regulatory application to the European Medicines Agency (EMA) in 2018. An EMA approval decision is expected in the first half of 2019.

Latest News

5 Biggest News Stories of the Week: June 23

Updated on June 24, 2022.  As the saying goes, the news never stops — but there’s a lot of it out there, and all of it doesn’t always pertain to our readers. In this weekly news roundup, we’ll cover the top news stories that matter most to our diversity focused…

How Feelings of Loneliness Can Affect Employees

As employees begin to return to the office – some part-time, some full-time – a clearer understanding is emerging of how severely COVID-19 impacted mental health. Among the many changes employees said they experienced while working remotely, the most common were feelings of loneliness caused by long periods of isolation….

Champions of Pride Part Two: Entertainers

Pride Month is a time to reflect on the trailblazers, freedom fighters, and history makers who fought valiantly to increase inclusion and representation for the LGBTQ community, and who have paved a way for a better tomorrow for future generations. In Part Two of our four-part series celebrating Champions of…

Educating Your Workforce on Juneteenth

Even as Juneteenth officially became a federal holiday in 2021, many employers likely have large portions of their workforce who remain unfamiliar with the details of the holiday. This month provides the perfect opportunity to explain the significance of Juneteenth not only for Black Americans but for all Americans. The…

5 Biggest News Stories of the Week: June 16

As the saying goes, the news never stops — but there’s a lot of it out there, and all of it doesn’t always pertain to our readers. In this weekly news roundup, we’ll cover the top news stories that matter most to our diversity focused audience. 1. Buffalo Supermarket Shooter…