On March 25, AstraZeneca announced that the European Medicines Agency (EMA) officially approved its SGLT-2 inhibitor, Forxiga (Dalagide) as adjunctive therapy for insulin, for optimal use of optimal doses of insulin to control poor blood sugar. Type 1 diabetes patients (BMI ≥ 27).
This is the first time that EMA has approved an oral drug as adjunctive therapy for insulin for patients with type 1 diabetes. It is the first drug approved by AstraZeneca for the treatment of type 1 diabetes. It is also the first time that SGLT-2 inhibitor has been approved for use in 1 Type 2 diabetes patients.
The EMA approval is based primarily on the results of the Phase III DEPICT clinical program in patients with type 1 diabetes. The 24-week short-term results of the DEPICT-1 study and the 52-week long-term results and the 24-week short-term results of the DEPICT-2 study showed that oral administration of Forxiga 5 mg once daily as an adjuvant therapy for patients with type 1 diabetes who had poor glycemic control with insulin alone The patient’s HbA1c level (primary endpoint), body weight (secondary endpoint), and daily insulin dose (secondary endpoint) can be clinically improved compared to baseline values.
In terms of safety, except for the slightly higher incidence of ketoacidosis, Forxiga’s adverse reaction data in patients with type 1 diabetes was consistent with previous data in patients with type 2 diabetes. Ketoacidosis is a common complication in patients with type 1 diabetes and is more common than patients with type 2 diabetes.
SGLT-2 is called sodium-glucose cotransporter-2, which is mainly expressed in the kidney. Its main function is to help the kidney reabsorb glucose. SGLT-2 inhibitor is a new type of diabetes drug listed in recent years. It is mainly used to reduce the reabsorption of glucose by the kidney and promote the hypoglycemic effect of excess glucose through the urine. It is regarded as a new treatment for diabetes different from traditional hypoglycemic agents. Pathway is also a hot target for diabetes drug development in recent years.
To date, seven SGLT-2 inhibitors have been approved worldwide, of which Toglietin, Rugliflozin, and Iglistine are approved only in Japan. Counting the three most-regarded SGLT-2 inhibitors (unpublished by Merck’s Egley Net), the market for SGLT-2 inhibitors has reached more than $2.9 billion.
From the growth trend of specific varieties, Caglifloz has suffered the most safety warnings. In 2018, it finally lost the top spot in the SGLT-2 field, and its share has shrunk year by year. Forxiga has been approved in the European Union and the United States as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes, and has demonstrated additional benefits in weight reduction, lowering blood pressure, and reducing the risk of cardiovascular events in clinical studies. The performance growth momentum is good.
Forxiga’s marketing application for insulin-assisted therapy for patients with type 1 diabetes has also been submitted in Japan and the United States, and results are expected to be available in the first half of 2019 and 2019, respectively. On March 22nd, the SGLT-1/2 dual inhibitor sotagliflozin jointly developed by Sanofi/Lexicon was rejected by the FDA for the treatment of type 1 diabetes. The specific reasons were not disclosed, but sotagliflozin was listed in the EU for this indication. The application has been approved by CHMP, and the official approval result will be processed until the second half of this year.