EMA officially approves AstraZeneca SGLT-2 inhibitor Forxiga (Dagre Net) for type 1 diabetes

recently, AstraZeneca announced that the EuropeanMedicines(http://Authority (EMA) has officially approved its SGLT-2 inhibitor Forxiga (Dageli Net) as an insulin-assisted therapy for patients with type 1 diabetes with poor blood sugar in the single optimal dose of insulin (BMI 27)THE EMA APPROVAL IS BASED PRIMARILY ON THE RESULTS OF THE PHASE III DEPICT CLINICAL PROGRAM IN PEOPLE WITH TYPE 1 DIABETESThe 24-week short-term results of the DEPICT-1 study and the 52-week long-term results, as well as the 24-week short-term results of the DEPICT-2 study, showed that 1 oral Forxiga 5mg per day as an auxiliary therapy for patients with type 1 diabetes with poor blood sugar alone could result in a clinically significant improvement in the patient's HbA1c level (primary endpoint), weight (secondary endpoint), daily insulin dose (secondary endpoint) over baseline valuesIn terms of safety
in addition to the slightly higher incidence of ketoacidosis, Forxiga's adverse reaction data in people with type 1 diabetes were consistent with previous data in people with type 2 diabetesKetoacidosis is a common complication in people with type 1 diabetes, more common than people with type 2 diabetesApplications for foremarketation of Forxiga
Forxiga as insulin-assisted therapy for patients with type 1 diabetes have also been submitted in Japan and the United States, with results expected in the first half of 2019 and 2019, respectivelyMarch 22, Sanofi/Lexicon jointly developed SGLT-1/2 dual inhibitor sotagliflozzin for the treatment of type 1 diabetes application was rejected by theFDA(http://, the reason suis not disclosed, although sotagliflozin for this indication in the European Union listing application has been confirmed by CHMP, the official approval results will not be made until the second half of this year