European commission approves Zynquista, first dual sglt inhibitor for t1d

#1

WRITTEN BY: Beyond Type 1 Editorial Team

New drug Zynquista (sotagliflozin), developed by Lexicon and Sanofi, has been granted marketing authorization by the European Commission for adults with Type 1 diabetes. The oral medication is an SGLT-1 and 2 inhibitor taken in addition to insulin. Zynquista is the first dual SGLT-1/2 inhibitor approved for use in Type 1 diabetes, and the second oral medication approved for use in Type 1 diabetes.

Trial results for Zynquista identified a notable reduction in HbA1c levels and increased time in range (between 70-180 mg/dl). Additionally, the medication has been shown to help reduce insulin requirements, assist with weight loss, and help prevent glucose spikes after meals. However, clinical research also showed that diabetic ketoacidosis (DKA) was noted to be substantially higher in trial patients using the drug. The European approval comes with a note that DKA risk must be addressed with appropriate patient selection, education, and ketone monitoring in place.

Just last month, the FDA declined to approve the same drug, citing safety concerns around possible increased risk of DKA. Preliminary recommendations from the Committee for Medicinal Products for Human Use (CHMP) in Europe had been considerably more positive than the recommendations from the FDA Advisory Committee in the United States. The FDA did not issue an outright rejection, but a “Complete Response Letter” likely asking for further data and risk management. Lexicon and Sanofi have announced that they will “work closely with the FDA to determine the appropriate next steps” for an approval of Zynquista in the United States.

Zynquista is an oral inhibitor of sodium-dependent glucose co-transporters 1 and 2, two proteins responsible for glucose regulation. SGLT-1 works in the gastrointestinal tract and SGLT-2 in the kidneys. SGLT-2 inhibitors have been used since 2013 in the United States by patients with Type 2 diabetes and are also used off-label by Type 1 patients.

Recognizable name brand SGLT-2 inhibitors currently approved for use in patients with Type 2 diabetes include Farxiga, Invokana and Jardiance. In addition to Zynquista, Farxiga (or Forxiga) was recently approved for use in Type 1 diabetes in Europe and Japan.

#2

While that sounds great, personally I’m never eager to take newly released medications. I’ve seen too many “wonder” drugs end up causing problems that are discovered long after their release. I hope this drug causes few bad side effects, isn’t too expensive w/ insurance, and does what it is purported to do. That would be awesome, eh?

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#3

Dave44, I’m with you on this. As an old nurse, I was surprised when Invokana and Farxiga were being heavily advertised that the most common side effects were the result of excretion of sugar in the urine—the signal sign of diabetes in the good old days, with urinary and vaginal infections for the ladies and balanitis (look it up) for the gents often being the reasons folks sought medical care. At least one article I read also reported “cases” of flesh-eating bacteria. IF the FDA does report it, it might need a “black box warning” re: education on hygiene and adequate fluid intake!