The FDA da Luz Green to the use of 'Trade' (Boehringer/Lilly)
05/17/2011 4:43 p.m.
The American Medication Agency (FDA) has authorized the use of linagliptin, marketed with the name of 'Trade' by Boehringer Ingelheim and Lilly, to reduce blood glucose levels in patients with diabetes mellitus type 2, in monotherapy or with other oral anti -abetics.
This drug belongs to a class of prescription drugs called Diphidyl Peptidase-4 inhibitors (DPP-4) and, as they point out, decrease blood sugar through an increase in incredine levels, thus achieving an insulin increaseNot only after meals but also throughout the day.
The clinical trials carried out, in which more than 4,000 patients have participated, have demonstrated a statistically significant reduction in glycosylated hemoglobin (HBA1C), the index used in clinical practice to monitor the control of blood glucose levels,up to 0.7 percent used in monotherapy.
Oral administration, it is the first of its class that is approved in concentration of a dose (5 milligrams once a day), and does not require dose adjustment for patients with renal or hepatic deterioration.
In addition, it is not indicated in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increase in blood or urine ketones).
According to the laboratories that market this drug, the approval of linagliptin by the FDA brand "The First Milestone" within the framework of the World Alliance of Boehringer Ingelheim and Eli Lilly and Company against diabetes, constituted in January 2011.
05/17/2011 4:43 p.m.
@fer - Diabetes Tipo 1 desde 1.998 | FreeStyle Libre 3 | Ypsomed mylife YpsoPump + CamAPS FX | Sin complicaciones. Miembro del equipo de moderación del foro.
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Hello, Fer and everyone.
I received this news in the Vademécum Bulletin, which usually send me periodically and in collation of it, I wanted to ask, in Spain which organism is the one that gives the approval to be able to market it?When can it be prescribed here?
Thank you very much and greetings.
05/17/2011 6:18 p.m.
Hello!In Spain they are the Spanish Agency for Medication and Health Products and the European Medication Agency those responsible for giving green light to the marketing of drugs and other health products.I do not know when they will authorize the commercialization, but if the FDA has already authorized it, I do not think it takes a long time.
greetings
05/17/2011 6:27 p.m.
Sometimes they can take even 1 year ... or even, sometimes the variability of technical and security criteria is incredible ...
We will also have to see the "commitment" of the laboratory in question ...
05/18/2011 4:17 p.m.