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Sanofi and Lexicon's Zynquista scores EU approval for type 1 diabetes patients

Published on 29/04/19 at 11:33am

The European Commission has authorised the use of Sanofi and Lexicon’s Zynquista (sotagliflozin) in Europe in the treatment of specific patients with type 1 diabetes (T1D), it has been revealed.

The oral SGLT1 and 2 inhibitor was approved in both 200 mg and 400 mg doses as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus and a body mass index ≥ 27 kg/m2, who could not achieve adequate control despite optimal insulin therapy.

“Millions of people across Europe who live with type 1 diabetes struggle to control their blood sugar, even with optimal insulin therapy,” commented Thomas Danne, Professor of Pediatrics at Children’s Hospital ‘Auf der Bult’ in Hannover, Germany. “For the many people living with type 1 diabetes who are overweight or obese, Zynquista will offer a new treatment option physicians can now consider in combination with insulin therapy for appropriate patients.”

Supportive Phase 3 evidence derived from around 3,000 T1D patients showed that Zynquista delivered “resulted in consistent and significant reductions from baseline” in average blood sugar levels, body weight and systolic blood pressure after 12 weeks in both doses compared to insulin alone, as well as “a significant improvement of time in target blood sugar range and improved patient-reported outcomes.”

“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 SGLT2 inhibition and delaying dietary sugar absorption through local SGLT1 inhibition in the intestinal tract,” commented Dr John Reed, Global Head of Research & Development at Sanofi.

Dr Pablo Lapuerta, Executive Vice President and Chief Medical Officer at Lexicon, added: “We are proud to have developed Zynquista in combination with insulin through the largest Phase 3 clinical trial programme to date in adults with type 1 diabetes, and now to have it approved in the European Union. We thank the European Commission for recognising the clinical benefits of Zynquista for adults with type 1 diabetes and the families and physicians who participated in the clinical trials.”

Matt Fellows

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