FDA panel split on Sanofi’s Type 1 diabetes hopeful Zynquista
by Carly Helfand |
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.
Continue here –> FiercePharma.com
