CHMP Backs Sanofi's Zynquista for Type 1 Diabetes in Overweight/Obese Patients

• The CHMP has recommended Sanofi's Zynquista (sotagliflozin) as an adjunct to insulin for type 1 diabetes patients with a BMI above 27kg/m2 who struggle to control blood glucose with insulin alone.
• This positive opinion follows three Phase III trials demonstrating improved blood sugar control, reduced weight and blood pressure, and decreased glucose level variability with sotagliflozin.
• Zynquista, an oral SGLT1/2 inhibitor, carries a risk of diabetic ketoacidosis (DKA), necessitating careful patient selection and insulin dose adjustments to mitigate this potentially life-threatening complication.
• If approved by the EMA, Zynquista will be the second SGLT inhibitor approved for type 1 diabetes in Europe, potentially generating $1.16 billion in sales by 2022.

The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Sanofi's Zynquista (sotagliflozin) as an adjunct therapy to insulin for adults with type 1 diabetes mellitus (T1DM). This recommendation applies specifically to overweight or obese patients, defined as those with a body mass index (BMI) equal to or greater than 27 kg/m2, whose blood glucose levels remain inadequately controlled despite insulin therapy.

The CHMP's decision is based on data derived from three Phase III clinical trials. These studies demonstrated that sotagliflozin, an oral SGLT1/2 inhibitor, can significantly improve glycemic control in this patient population. Benefits observed included reductions in weight and blood pressure, alongside a decrease in the variability of glucose levels. The trials also suggested that Zynquista could improve blood glucose levels without increasing the risk of hypoglycaemia.

Safety Considerations

However, the CHMP also highlighted a critical safety concern: the increased risk of diabetic ketoacidosis (DKA) associated with SGLT inhibitor use in T1DM. DKA is a potentially life-threatening condition that can lead to acute kidney injury, respiratory failure, and death. To mitigate this risk, the CHMP recommends careful patient selection, excluding slimmer individuals from treatment with Zynquista. Furthermore, fine-tuning of insulin dosage is advised to minimize the likelihood of DKA development.

Competitive Landscape

If approved by the European Medicines Agency (EMA), Zynquista will become the second SGLT inhibitor approved for use alongside insulin in type 1 diabetes, following AstraZeneca’s Forxiga (dapagliflozin). The approved indication for Forxiga is nearly identical to that of Zynquista, including the BMI restriction.

Sanofi's Diabetes Portfolio

The positive CHMP opinion offers a boost to Sanofi's diabetes franchise, which has faced challenges in recent years due to patent expirations and evolving market dynamics. Zynquista, developed in partnership with Lexicon Pharma, represents a key pipeline asset for Sanofi as the company strategically refocuses its R&D efforts. EvaluatePharma consensus forecasts project potential sales of $1.16 billion for Zynquista by 2022.