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SGLT-2 inhibitor was first approved for the treatment of type 1 diabetes

On March 25, Astrazeneca announced that the European Medicines Agency (EMA) formally approved its SGLT-2 inhibitor Forxiga (dagliflozin) as an adjuvant therapy to insulin in patients with type 1 diabetes mellitus (BMI≥27) who have poor glycemic control with optimal doses of insulin alone.
This is the first time an oral drug has been approved by the EMA as an adjunct to insulin in patients with type 1 diabetes, the first time Astrazeneca has approved a drug for the treatment of type 1 diabetes, and the first time an SGLT-2 inhibitor has been approved for use in patients with type 1 diabetes.
The EMA's approval is based mainly on results from a phase III week clinical programme in patients with type 1 diabetes. The 24 week and 52 week short-term results from the DEPICT-1 and 24 week results from the DEPICT-2 results show that: Oral Forxiga 5mg once daily as an adjunct therapy in patients with type 1 diabetes mellitus who have poor glycemic control with insulin alone resulted in clinically meaningful improvements from baseline in HbA1c levels (primary end point), body weight (secondary end point), and daily insulin dose (secondary end point).
In terms of safety, the data on adverse effects of Forxiga in patients with type 1 diabetes were consistent with previous data in patients with type 2 diabetes, except for a slightly higher incidence of ketoacidosis. Ketoacidosis is a common complication in patients with type 1 diabetes and is more common than in patients with type 2 diabetes.
SGLT-2, known as sodium-glucose cotransporter 2 in Chinese, is mainly expressed in the kidney, and its main role is to help the kidney reabsorb glucose. SGLT-2 inhibitor is a new type of diabetes drug marketed in recent years, which mainly plays a hypoglycemic effect by reducing the reabsorption of glucose in the kidney and promoting the excretion of excess glucose through urine. It is regarded as a new way of diabetes treatment different from traditional hypoglycemic drugs, and is also a popular target for the development of diabetes drugs in recent years.
Up to now, a total of 7 SGLT-2 inhibitors have been approved globally, among which toagliflozin, ruagliflozin and igliflozin have only been approved in Japan. A tally of the three most closely watched SGLT-2 inhibitors (Merck's net sales of egaglil are not disclosed) shows that the market size of SGLT-2 inhibitor drugs has exceeded $2.9 billion.
In terms of the growth trend of specific varieties, canagliflozin lost the top position in the SGLT-2 segment at the end of 2018 due to the most safety warnings, and its share has been shrinking 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 mellitus, and has demonstrated additional benefits in clinical studies for weight loss, lower blood pressure, and lower risk of cardiovascular events.
Marketing applications for Forxiga as an adjuvant insulin therapy for patients with type 1 diabetes have also been filed in Japan and the United States, with results expected in the first half of 2019 and 2019, respectively. On March 22, Sanofi /Lexicon's SGLT-1/2 dual inhibitor sotagliflozin was rejected by the FDA for the treatment of type 1 diabetes for undisclosed reasons, although sotagliflozin's application for this indication in the European Union has received a positive recommendation from CHMP. Formal approval is not expected until the second half of this year.
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