Zynquista now approved in the European Union for treatment of adults with type 1 diabetes

PARIS and THE WOODLANDS, TX – April 26, 2019 – The European Commission
has granted marketing authorization for Zynquista (sotagliflozin), developed by
Sanofi and Lexicon. Zynquista is now approved in the European Union, at once-daily
doses of 200 mg and 400 mg, for use as an adjunct to insulin therapy to improve blood
sugar (glycemic) control in adults with type 1 diabetes (T1D) mellitus and a body mass
index ≥ 27 kg/m2
, who could not achieve adequate glycemic 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, Children’s Hospital ‘Auf der Bult,’
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.”
Zynquista is an oral dual inhibitor of two proteins responsible for glucose regulation
known as sodium-dependent glucose co-transporter types 1 and 2 (SGLT1 and
SGLT2).1 SGLT1 is responsible for glucose absorption in the gastrointestinal tract,2
and SGLT2 is responsible for glucose reabsorption by the kidney.3
“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,” added John Reed, M.D.,
Ph.D., Global Head of Research & Development, Sanofi.
The marketing authorization is based on evidence including data from the inTandem
clinical trial program, which included three Phase 3 clinical trials assessing the safety
and efficacy of sotagliflozin, involving approximately 3,000 adults with inadequately
controlled T1D.
“We are proud to have developed Zynquista in combination with insulin
through the largest Phase 3 clinical trial program to date in adults with type 1
diabetes, and now to have it approved in the European Union,” said Pablo
Lapuerta, M.D., Executive Vice President and Chief Medical Officer, Lexicon.
“We thank the European Commission for recognizing the clinical benefits of
Zynquista for adults with type 1 diabetes and the families and physicians who
participated in the clinical trials.”
These three trials demonstrated that treatment with sotagliflozin, when given to adults
with inadequately controlled T1D as an oral adjunct to insulin, resulted in consistent
and significant reductions from baseline at 24 weeks in average blood sugar (HbA1c),
body weight, systolic blood pressure, a significant improvement of time in target blood
sugar range and improved patient-reported outcomes, versus insulin alone, at both
200-mg and 400-mg doses.
4-7 This was achieved without the usual increase in severe
hypoglycemia that comes with intensification of insulin and with less events of severe
hypoglycemia in the 400-mg dose at 52 weeks.
Consistent with selective SGLT2 inhibitors, clinical trials with sotagliflozin showed an
increased risk of genital mycotic infections and diabetic ketoacidosis (DKA), which is
acknowledged to affect people with T1D more frequently than those with type 2
diabetes (T2D). Several leaders in the diabetes scientific community consider the risk
of DKA associated with SGLT inhibitors manageable with appropriate patient selection,
education and ketone monitoring in place.
8-11 The risk of DKA will be addressed by
careful selection of patients for treatment with sotagliflozin and through a riskmanagement plan and a mitigation strategy, including patient, healthcare professional
and care giver educational activities, that will support its safe use.
Zynquista is also currently being evaluated in a program of 11 clinical trials in adults
with T2D, including two trials in people living with T2D and renal impairment, and two
large cardiovascular outcomes trials.
Zynquista (sotagliflozin) is not currently approved for use in any other markets, where it is considered an
investigational product.

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