Sanofi, Lexicon's Zynquista approved in EU for use in certain patients with type 1 diabetes

Sanofi and Lexicon Pharmaceuticals on Friday announced that the European Commission has authorised the SGLT-1/SGLT-2 inhibitor Zynquista (sotagliflozin) as an adjunct to insulin therapy in adults with type 1 diabetes and a body mass index of at least 27 who failed to achieve adequate glycaemic control despite optimal insulin therapy. The approval follows a positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use in March. Shares in Lexicon surged as much as 13 percent on news of the approval. 

John Reed, global head of R&D at Sanofi, remarked "Zynquista's dual mechanism of action provides important treatment benefits for adults with type 1 diabetes, including reducing blood sugar reabsorption in the kidneys through SGLT-2 inhibition and delaying dietary sugar absorption through local SGLT-1 inhibition in the intestinal tract." 

Approval of the drug was supported by data from the inTandem clinical trial programme, which included three late-stage studies. Results from the inTandem1 trial showed that Zynquista significantly reduced A1C levels at 24 weeks in patients with type 1 diabetes on a background of optimised insulin, with similar findings obtained in the inTandem2 study. Meanwhile, the inTandem3 trial demonstrated the superiority of Zynquista over placebo in the proportion of patients with glycosylated A1C levels of less than 7 percent at 24 weeks, with no episodes of severe hypoglycaemia or diabetic ketoacidosis after randomisation.

Meanwhile, the FDA declined to clear Zynquista last month. The companies did not specify a reason at the time, although an advisory panel to the agency was split on whether the drug's benefits outweighed its risks, while FDA staff had expressed concerns about its potential links to elevated risks of diabetic ketoacidosis. 

Sanofi was granted an exclusive global licence to develop and commercialise Zynquista from Lexicon in 2015 under a deal worth up to $1.7 billion. 

To read more Top Story articles, click here.