The Human Use Medicines Committee (CHMP) of the European Medicines Agency (EMA) has first recommended a complementary oral treatment insulin for certain patients with type 1 diabetes. The definitive decision on the approval of Dapaglifozine indication extension(of Astrazeneca) now falls to the European Commission.
Dapagliflozina is already authorized in the European Union such as Forxiga and Edistide for the treatment of patients with type 2 diabetes.
It belongs to a new generation of diabetes drugs called selective SGLT2 inhibitors that act in the kidneys to prevent the reabsorption of urine glucose into the blood torrent and thus reduce the blood sugar level.
new indication
Following the data of new clinical trials, the CHMP recommends extending the indication to certain patients with type 1 diabetes mellitus when the insulin alone does not provide adequate control of its blood glucose levels despite the optimal treatment with insulin therapy.Patients considered for this treatment must meet certain requirements and should not have a body mass index (BMI) below 27 kg / m2.
The EMA remembers that despite the improvements in insulins, the administration and blood cell control systems, a proportion of type 1 diabetics cannot reach or maintain the recommended levels of glucose in the blood only with insulin.
Hyper and hypoglycemia and weight gain are associated common problems and their life expectancy remains significantly lower compared to the general population, mainly due to the greater risk of heart disease.Therefore, there is a need for new complementary therapies to insulin to improve glycemic control and other cardiovascular risk factors.
endorsement of clinical trials
The positive opinion is based on data from two phase III studies with 548 patients with type 1 diabetes. The results showed benefits in glycemic control, weight reduction, effects on blood pressure and reduced variability of glucose levels.
The data submitted with this application also shows that despite the precautionary measures, there is a considerable increase in the risk of diabetic ketoacidosis, a potentially deadly complication.
Because the increase in risk is worrisome, the CHMP recommends limiting dapaglifozine use in type 1 diabetes. Specifically, treatment should only be considered in overweight patients or obese with an BMI greater than or equal to 27. Its use is not recommendedIf there is a low insulin requirement.During the treatment with Dapagliflozine, insulin therapy should continually optimize to prevent ketosis and diabetic ketoacidosis, and insulin dose should only be reduced to avoid hypoglycemia.
In addition, the agency indicates that this treatment must only be initiated and supervised by specialist doctors.Patients should commit to control ketone levels in their body and should receive training about the risk factors of this complication and how to recognize their signs and symptoms.