On March 25, AstraZeneca announced that the European Medicines Agency (EMA) officially approved its SGLT-2 inhibitor Forxiga (Dapagliflozin) as an adjunctive therapy of insulin for Type 1 diabetes patients with poor blood glucose (BMI ≥ 27) who only used the optimal dose of insulin.
This is the first time that EMA approved an oral drug as an adjunctive therapy of insulin for patients with Type 1 diabetes, the first drug approved by AstraZeneca to treat Type 1 diabetes, and the first time that SGLT-2 inhibitor was approved for patients with Type 1 diabetes.
EMA's approval is mainly based on the results of the Phase III DEPICT clinical project in patients with Type 1 diabetes. The 24 week short-term results of DEPICT-1 study, the 52 week long-term results of DEPICT-2 study and the 24 week short-term results of DEPICT-2 study all showed that once daily oral administration of Forxiga 5mg as an adjuvant therapy for Type 1 diabetes patients with poor glucose control by insulin alone could achieve clinically significant improvements in the HbA1c level (the primary endpoint), body weight (the secondary endpoint), and daily insulin dosage (the secondary endpoint) of patients compared with the baseline value.
In terms of safety, except that the incidence of ketoacidosis is slightly higher, the adverse reaction data of Forxiga in patients with Type 1 diabetes is consistent with the previous data in patients with type 2 diabetes. Ketoacidosis is a common complication of Type 1 diabetes patients, which is more common than type 2 diabetes patients.
SGLT-2, also known as sodium glucose co transporter-2 in Chinese, is mainly expressed in the kidneys and its main function is to help the kidneys reabsorb glucose. SGLT-2 inhibitor is a new type of diabetes drug that has been marketed in recent years. It plays a hypoglycemic role mainly by reducing the re absorption of glucose by the kidney and promoting the excretion of excess glucose through urine. It is regarded as a new way to treat diabetes different from traditional hypoglycemic drugs, and is also a hot target for drug development of diabetes in recent years.
As of now, a total of 7 SGLT-2 inhibitors have been approved for marketing globally, among which Toggliflozin, Rugliflozin, and Iggliflozin have only been approved in Japan. According to the statistics of the three most closely watched SGLT-2 inhibitors (net sales of MSD Egli not disclosed), the market size of SGLT-2 inhibitor drugs has exceeded 2.9 billion US dollars.
From the perspective of the growth trend of specific varieties, due to the highest number of safety warnings, Kagliflozin finally lost its top spot in the SGLT-2 field in 2018, and its share has been shrinking year by year. Forxiga has been approved in the European Union and the United States as an adjunctive therapy of diet and exercise to improve blood sugar control in patients with type 2 diabetes, and has been proved in clinical research to have additional benefits in weight loss, blood pressure reduction, and cardiovascular event risk reduction, with a good growth momentum in sales performance.
Forxiga's marketing application for insulin adjuvant therapy for patients with Type 1 diabetes has also been submitted in Japan and the United States, and it is expected that results will be obtained in the first half of 2019 and 2019 respectively. On March 22, SG jointly developed by Sanofi/Lexicon