EU Panel OKs Sotagliflozin for Some With Type 1 Diabetes

Miriam E. Tucker

Disclosures

March 01, 2019

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for sotagliflozin (Zynquista, Sanofi) as adjunctive treatment with insulin for certain adults with type 1 diabetes and under strict conditions.

The decision likely means that the EMA will allow use of both 200-mg and 400-mg doses of the dual sodium-dependent glucose cotransporter 1 (SGLT1) and SGLT2 inhibitor in patients with type 1 diabetes who don't achieve optimal glycemic control with insulin alone and who meet specific requirements aimed at avoiding diabetic ketoacidosis (DKA).

If approved, which is normally a formality within 60 days, the EU would be the first market worldwide for sotagliflozin.

In February, a 16-member US Food and Drug Administration (FDA) advisory panel was evenlysplit on a vote for recommending approval of the drug in patients with type 1 diabetes, with even those in favor citing concerns about the increased risk for DKA.

The target date for FDA action under the Prescription Drug User Fee Act is anticipated to be March 22, 2019.

Strict Conditions for Use of Sotagliflozin in the EU

Indeed, in attempts to minimize the DKA risk, the CHMP recommendation comes with a list of conditions for use of sotagliflozin in patients with type 1 diabetes:

  • It should be considered only in those who are overweight or obese with a body mass index (BMI) above 27 kg/m2.

  • It is not recommended for patients with low insulin requirements.

  • During treatment, insulin therapy should be continuously optimized to prevent ketosis and DKA, and insulin doses lowered only to avoid hypoglycemia.

  • Only specialist physicians should initiate and supervise sotagliflozin treatment.

  • Patients should be "able and committed" to control their ketone levels and should be educated about risk factors for and how to recognize the signs and symptoms of DKA.

The CHMP's positive opinion is based on data from three phase 3 studies of 2980 patients with type 1 diabetes. Sotagliflozin significantly reduced HbA1c compared with placebo, as well as glycemic variability, blood pressure, and weight.

However, DKA occurred in about 3% of patients treated with sotagliflozin — nearly triple the rate with placebo — despite rigorous patient and investigator education and the provision of ketone home monitoring kits to patients in the trials.

In February, CHMP recommended authorization for the SGLT2 inhibitor dapagliflozin (Forxiga/Farxiga/Edistride, AstraZeneca) for use in patients with type 1 diabetes under similar restrictions.

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