FDA panel split on Sanofi's Type 1 diabetes hopeful Zynquista

Should the FDA approve Sanofi’s SGLT1/2 candidate for patients with Type 1 diabetes? Turns out, the experts can’t agree.

On Thursday, an advisory panel was split—voting 8-8—on whether the overall benefits of the drug, dubbed Zynquista, outweigh its risks. Now, it’ll be up to the FDA to decide which group to side with; its verdict is due by March 22.

Sanofi and partner Lexicon are looking to sell the drug, a dual inhibitor that targets both SGLT1 and SGLT2, as an oral add-on to insulin. If they can pull off a green light, Zynquista would be the first oral diabetes drug to score U.S. approval in tandem with insulin to improve blood sugar control in patients with Type 1 diabetes, the French drugmaker said.

The way the companies see it, an FDA approval is warranted, considering that in trials Zynquista “significantly improved glycemic control without increasing hypoglycemia," Pablo Lapuerta, M.D., Lexicon EVP and chief medical officer, said in a statement, adding. "These results could not be achieved with insulin alone.”

And while he acknowledged the drug did increase the risk of diabetic ketoacidosis—a serious complication that results from too little insulin—he also said the drugmakers “believe this can potentially be addressed with proper education and monitoring.”

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Sanofi and Lexicon certainly hope regulators see things their way. Diabetes woes are set to drag on Sanofi’s sales once again this year, CFO Jean-Baptiste Chasseloup de Chatillon said at the J.P. Morgan Healthcare Conference last week.

“The diabetes impact will be less than last year but will still affect 2019,” he said.

But a new patient pool would help matters. About 1.3 million Americans have Type 1 diabetes, and an estimated 40,000 people are newly diagnosed each year in the U.S., according to the American Diabetes Association. Sanofi would be the first to take an SGLT2 drug into that arena; right now, competitors from Johnson & Johnson, AstraZeneca, the Eli Lilly-Boehringer Ingelheim team and a Merck-Pfizer pairing only play in Type 2.