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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended an additional indication for dapagliflozin (Forxiga / Farxiga / EdistrideAstraZeneca) in adults with type 1 diabetes who meet certain criteria.
The drug, a selective inhibitor of sodium-glucose cotransporter 2 (SGLT2), is already approved for the treatment of type 2 diabetes in the European Union, the United States and elsewhere.
If this new use within the European Union was accepted, usually a formality, dapagliflozin would be the first complementary oral insulin treatment for type 1 diabetes in the world.
In order to alleviate the risk of diabetic ketoacidosis (DKA) in patients with type 1 diabetes in trials involving multiple SGLT2 inhibitors, the indication proposed by the WHO was confirmed. EU limits the use of dapagliflozin in patients with type 1 diabetes with a body mbad index of 27 kg / m2 or more that do not achieve glycemic goals despite high insulin doses.
Insulin doses should be continuously optimized during treatment with dapagliflozin by a diabetes specialist and only reduced to prevent hypoglycemia.
And patients should be given instructions to control ketone levels and recognize the risk factors as well as the signs and symptoms of ACD.
The CHMP positive opinion was based on data from two Phase 3 clinical trials of the clinical DEPICT program (clinical evaluation of dapagliflozin in patients with inadequately controlled type 1 diabetes).
As previously indicated by Medscape Medical News, DEPICT-1 and DEPICT-2 were both double-blind randomized trials with long-term extensions of up to 52 weeks, each comprising about 800 patients. In both trials, significant reductions in HbA1 C (primary endpoint), weight and total daily insulin dose were achieved with 5 mg and 10 mg doses of dapagliflozin.
DKA levels were approximately equal across groups in DEPICT-1, in 1% to 2% of the dapagliflozin and placebo groups. In DEPICT-2, there was a slight but significant increase in DKA with the drug, up to 2.6% with the 10 mg dose, compared to no case with placebo.
However, many experts are concerned that the risk of ACD will be much greater if these agents are used in real-life conditions without close monitoring during clinical trials.
This concern was expressed at a recent meeting of the US Food and Drug Administration's Advisory Committee on sotagliflozin (Sanofi / Lexicon), a dual inhibitor of SGLT1 and SGLT2.
The vote of this panel was divided at the center, 8-8, on whether the benefits outweighed the risks badociated with the drug as an additive for type 1 diabetes, and even those who voted in favor of it have strongly recommended for the mitigation of risks badociated with ACD. Some have advised the company to provide patients with ketone test kits for patients.
An FDA decision on the approval of sotagliflozin is expected by the end of March.
Dapagliflozin is currently undergoing regulatory review in the United States and Japan for use as an insulin replacement therapy in adults with type 1 diabetes. .
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