The Medical Products Committee for Human Use (CHMP), of the European Medicine Agency (EMA), has recommended approved injectable solution, marketed by Lilly with the name of 'with the name of'Trulicity ', as weekly therapy to improve glycemic control in adults with type II diabetes.
'Trulicity' will be offered to patients in a pen ready for dose administration, with a hidden needle that has already been pre -finished.
"The positive recommendation of the CHMP, created in Lilly's laboratories and designed taking into account the patient, further strengthens Lilly's extensive commitment in the treatment of diabetes and in improving the quality of life of patients.Approve in the European Union, 'Trulicity', with its pen ready to be administered, will mean an important alternative for the treatment of type II diabetes and for patients in which their first injectable therapy is being raised, "said the vice presidentLilly Diabetes, David Kendall.
The positive opinion is based, in part, on the results of several studies, including six large clinical trials phase III of the Clinical Development Program 'Weekly Administration Evaluation of LY2189265 in Diabetes'.In the first five trials, 'Trulicity' 1.5 milligrams (MG) was higher than placebo and four medications commonly used in the treatment of diabetes to reduce the average blood sugar levels (HBA1C).
test results
Likewise, 'Trulicity' 0.75 mg reached similar HBA1C reductions in one of the trials, and demonstrated superiority in the other four.In the sixth essay, 'Trulicity' 1.5 mg showed HBA1C reductions similar to the highest approved dose of the GLP-1 agonist of the most common use that is administered once a day and that is usually used.
The frequently detected adverse events were gastro-foresting and when used in combination with prandial insulin or added to more glymepirid metformin, documented symptomatic hypoglycemia (low blood sugar levels).These adverse events are consistent with those observed with other GLP-1 recipient agonists.
If approved, 'Trulicity' will be provided with patients in a preloaded pen ready for dose administration and whose needle is introduced into the skin by clicking a button to retract automatically, without the need to see or manipulate the needle during self -administering.
The recommended dose will be 1.5 mg once a week for patients who are going to use 'Trulicity' in combination with other treatments for the glycemic control of their diabetes.'Trulicity' 0.75 mg is the recommended dose for use in monotherapy, as well as an initial dose for certain vulnerable populations, including patients of 75 years or more.
Dreamaglutida received the approval of the American Drug Agency (FDA) on September 18, 2014 and has pending applications in other regulatory agencies.