An advisory committee of the Food and Drug Administration (FDA) voted in a tie yesterday on the approval of a novel type 1 diabetes drug which would be sold under the brand name, Zynquista™.
The drug, also known as sotagliflozin, is being developed by drug makers Sanofi and Lexicon Pharmaceuticals. It is an investigational oral dual SGLT1 and SGLT2 inhibitor. It is under review as an adjunct to insulin for the treatment of adults with type 1 diabetes.
If approved, the drug has the potential to be the first oral antidiabetic drug approved in the U.S. together with insulin therapy to improve glycemic (blood sugar) control in adults with type 1 diabetes, according to a company statement.
“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 Dr. Rachele Berria, global vice president and head of diabetes medical affairs at Sanofi in a statement.
“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,” she added.
The New Drug Application for sotagliflozin included data from the in Tandem 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 type 1 diabetes.
The safety and efficacy data of the drug have not yet been fully evaluated by any regulatory authority.
In patients who were given the drug, there were 56 cases of diabetic ketoacidosis in 1,748 patients or 3.2 percent. In patients who took the placebo, however, there were only 5 cases out of 1,229 patients, or 0.4 percent.
Diabetic ketoacidosis, which is always a risk for people with type 1 diabetes, can result in serious hospitalization or death.
“I didn’t think it was ready for prime time,” Dr. Jack A. Yanovski, of the National Institutes of Health, said in a New York Times article. Yanovski voted against approval of the drug. “The degree of benefit is small enough that it’s not clear that it could overwhelm the increased risk for very serious complications,” he stated.
The 8-8 vote sends the decision back to the FDA, which is not required to follow the committee’s vote. However, the agency considers the recommendations when making its decision.
The final decision is anticipated by March 22, 2019.
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.
- FDA advisory committee votes on Zynquista™ (sotagliflozin) as treatment for adults with type 1 diabetes. (2019, Jan. 17) Retrieved 2019, Jan. 18. http://hugin.info/152918/R/2231739/877460.pdf
- Thomas, Katie. (2019, Jan. 17). F.D.A. Panel Splits on Whether to Approve New Diabetes Drug. The New York Times. Retrieved 2019, Jan. 18 from https://www.nytimes.com/2019/01/17/health/fda-diabetes-drug-sanofi.html
- Terry, Mark. 2019, (2019, Jan. 18). The Ball’s in the FDA’s Court: AdCom Vote Splits 50/50 on Type 1 Diabetes Drug. Retrieved 2019, Jan. 18 from https://www.biospace.com/article/the-ball-s-in-the-fda-s-court-adcom-vote-splits-50-50-on-type-1-diabetes-drug/?s=74