CHMP okays Sanofi’s Zynquista in type 1 diabetes

Sanofi has moved a step closer to getting its new diabetes therapy Zynquista approved in Europe, with a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency (EMA) drugs advisory panel has recommended the oral SGLT1/2 inhibitor as an adjunct to insulin for patients with type 1 diabetes who can’t maintain blood glucose control using insulin alone, but only in patients who are overweight or obese, i.e. with a body mass index (BMI) above 27kg/m².

The positive outcome is something of a relief for Sanofi after an FDA advisory committee delivered a split 8 to 8 vote on Zynquista (sotagliflozin) as an oral add-on to insulin last month, making predicting the FDA verdict due on 22 March something of a coin toss.

If the EMA follows the CHMP’s advice, Zynquista will become the second SGLT-acting drug to be approved for use alongside insulin in type 1 diabetes after AstraZeneca’s SGLT2 inhibitor Forxiga (dapagliflozin), which was given a green light by the CHMP a month ago. Forxiga’s approved indication is almost identical to that of Zynquista, right down to the BMI restriction.

The CHMP said its positive opinion is based on data from three phase III studies which showed treatment with sotagliflozin could improve blood sugar control, as well as reducing weight and blood pressure and the variability of glucose levels.

The trials suggest that Zynquista can improve blood glucose levels without increasing the risk of hypoglycaemia, although the drug – like Forxiga – carries a risk of diabetic ketoacidosis (DKA) – a potentially life-threatening complication which can lead to acute kidney injury, respiratory failure, and death – when added to insulin.

For that reason slimmer patients shouldn’t receive the combination and other measures, such as fine-tuning the insulin dose administered, are recommended, according to the CHMP. The risk of DKA was the primary reason for the split vote by the FDA’s advisory committee.

Sanofi’s lofty position in diabetes has been undermined in the last few years by the loss of patent protection for its biggest-selling product Lantus (insulin glargine) and disappointing take-up of newer long-acting insulin product Toujeo.

Zynquista – partnered with Lexicon Pharma – is one of the few candidates coming through the pipeline to make up the shortfall as Sanofi has been re-focusing its R&D towards other areas such as inflammatory and rare diseases.

Diabetes and cardiovascular took the brunt of an early R&D spring clean announced at the French drugmaker last month, accounting for six out of 13 projects in development culled including dual GLP-1/GIP agonists for type 2 diabetes.

Consensus forecasts from EvaluatePharma suggest Zynquista could have sales of $1.16 billion by 2022.