Release date: 2015-09-30
- The first non-vitamin K oral anticoagulant specific reversal agent to obtain positive evaluation of CHMP
- Positive evaluation is based on clinical studies, which show that idarucizumab can reverse the anticoagulant effect of dabigatran within a few minutes
The European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) gave a positive evaluation of idarucizumab (with Praxbind® as a trade name) and recommended it for approval in Europe. If approved, idarucizumab will be used to rapidly reverse the anticoagulant of dabigatran when adult patients receiving tibiolide (dabigatran) require emergency surgery/interventional procedures or life-threatening or uncontrolled bleeding complications. effect.
Professor of the European Cardiovascular Association, Professor Fausto J. Pinto of the University of Lisbon, Portugal, pointed out: "The positive evaluation of the approval of idarucizumab by CHMP is an important recommendation in the field of anticoagulant therapy. The birth of non-vitamin K oral anticoagulants (NOACs) is already anticoagulation. A major advance in the field. Approving specific reversal agents to quickly stop the anticoagulant effects of these drugs will be the next step."
President of the European Stroke Organization, Professor Kennedy R. Lees of the University of Glasgow, UK, commented: “For those stroke patients who receive anticoagulant drugs such as dabigatran, this is like a frosting on a cake: in an emergency we will It is possible to turn the effects of the drugs they receive quickly and safely. This will make treatment options easier for doctors and patients."
The CHMP positive evaluation was based on experimental data from healthy subjects and the interim analysis results of the RE-VERSE AD? study. In these studies, the reversal of idarucizumab appeared rapidly within a few minutes after the use of 5 grams of the drug. The reversal effect is complete and long-lasting in almost all patients. No serious adverse events related to idarucizumab were found. In addition, no procoagulant effect occurred after the use of idarucizumab.
“Our scientists have done in-depth and long-lasting research for idarucizumab, so now we are very excited about the approval of recommendations in Europe,†said J. Rg Kreuzer, vice president of medicine for cardiovascular therapy in Boehringer Ingelheim. “I believe in idarucizumab It will increase the confidence of doctors and patients to choose dabigatran because dabigatran is the first NOAC with a specific reversal agent."
Idarucizumab is currently in the process of global regulatory approval, including the US FDA. Boehringer Ingelheim plans to submit a listing application for idarucizumab in all countries approved by Dabiga.
About clinical research plan of idarucizumab
Idarucizumab was developed by the scientists of Boehringer Ingelheim. Its research program was launched in 2009, ahead of Dabiga Group's 2010 time to market in the United States. The company completed three Phase I clinical studies in healthy subjects and continued to evaluate the effects of idarucizumab in the RE-VERSE AD® study (NCT 02104947, EudraCT 2013â€004813â€41). RE-VERSE AD? is a global phase III clinical study that includes patients who require emergency surgery or uncontrolled bleeding complications when receiving dabigatran. The study, the first of a class of drugs to be performed in patients, was launched in May 2014 and included patients in more than 35 countries. The RE-VERSE AD? Global Phase III clinical study is underway to obtain further data on the efficacy and safety of idarucizumab.
About idarucizumab
Idarucizumab is a human antibody fragment (Fab) that is a specific reversal agent for dabigatran. Idarucizumab only binds specifically to the dabigatran molecule, neutralizing its anticoagulant effect and does not interfere with the coagulation cascade.
Idarucizumab is recommended for rapid reversal of anticoagulation of dabigatran when adult patients receiving tacrolimus (dabigatran) require emergency surgery/interventional procedures or life-threatening or uncontrolled bleeding complications effect.
Other countries are conducting regulatory review and submission of application materials. Idarucizumab is currently the only NOAC-specific reversal agent that is undergoing regulatory review. Boehringer Ingelheim plans to submit a listing application for idarucizumab in all countries approved for dabigatran.
Source: Bio Valley
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