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    Home > Medical News > Medical World News > Approved extended indications of Sanofi long-acting insulin for the benefit of patients with type 1 diabetes

    Approved extended indications of Sanofi long-acting insulin for the benefit of patients with type 1 diabetes

    • Last Update: 2019-11-28
    • Source: Internet
    • Author: User
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    Recently, the U.S FDA approved the extension of toujeo, a long-acting insulin glargine injection from Sanofi, for the treatment of children and adolescents with type 1 diabetes mellitus aged 6 and above Based on the results of the edition junior trial published earlier this month, the European Drug Administration (EMA) Committee on human drugs (CHMP) also recommended the approval of extended indications Previously, toujeo was only approved for treatment of adults 18 and older Type 1 diabetes mellitus is an autoimmune disease in children, which is characterized by immune-mediated loss of β cell function According to statistics, in the United States, one in 300 people under the age of 18 has type 1 diabetes Type 1 diabetes is an insulin-dependent diabetes mellitus Patients need to deal with the fluctuation of blood glucose frequently Ketosis and ketoacidosis can be caused by hyperglycemia, and hypoglycemia can be caused by hyperglycemia Managing blood sugar fluctuations is particularly challenging for children and adolescents Toujeo is a long-acting insulin glargine injection with insulin content three times that of standard 1ml insulin (100 units / ml), which was approved by FDA in 2015 The main activity of insulin is to regulate glucose metabolism, through stimulating peripheral glucose uptake, especially the uptake of glucose by skeletal muscle and fat, and through inhibiting the production of liver glucose to achieve the effect of lowering blood glucose This approval is based on the results of a test called edition junior The aim of the trial was to verify the efficacy of toujeo in the treatment of type 1 diabetes mellitus patients aged 6 to 17 years The results showed that after 6 months of treatment, compared with toujeo gla-100, the patients in toujeo treatment group achieved the non inferiority standard of reducing HbA1c level and reached the main end point of the study In addition, the incidence of ketosis and severe hypoglycemia (< 54 mg / dl) were relatively lower in this group, which had the effect of managing blood glucose fluctuation "Globally, 50-80% of patients with type 1 diabetes need more treatment options in order to reach the treatment goal of HbA1c level lower than 7.5%," said Dr Dietmar Berger, global development director of Sanofi "We hope to provide a new treatment method for children and young people with diabetes through clinical research Help them better control the disease by developing individualized treatment programs " reference material: [1] FDA approves higher-dose insulin glargine for children with diabetes Retrieved November 27, 2019, from https:// A kind of
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