![]() ![]() More than 3 million Americans have atrial fibrillation, a problem with the electrical system of the heart that causes an irregular heart rhythm. ![]() Unger, M.D., Director of FDA’s Center for Drug Evaluation and Research’s Office of Drug Evaluation I in the Office of New Drugs, discusses atrial fibrillation along with oral anticoagulant drugs and their reversal agents. "The availability of Praxbind now provides a unique option for reversing anticoagulation in patients taking Pradaxa.Ellis F. While general management strategies for NOAC-related bleeding are available, until today, there was no option for specific and immediate reversal of the anticoagulant effect of a NOAC in a patient in rare emergencies where speed matters, such as life threatening bleeding or the need to quickly perform surgery or interventions," said Dr Charles Pollack, lead investigator, RE-VERSE AD, professor of Emergency Medicine, Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, USA. "The emergence of novel oral anticoagulants, or NOACs, marked a significant advancement in anticoagulation care. The FDA granted Praxbind breakthrough therapy designation and the application received priority review. While we anticipate that Praxbind will be rarely used in clinical practice, the availability of a specific reversal agent has the potential to give physicians and patients added confidence in choosing Pradaxa." "With this approval, Boehringer Ingelheim is leading the evolution of anticoagulation care, as we did with the introduction of Pradaxa. "We are very pleased to offer Praxbind, the first specific reversal agent for a novel oral anticoagulant, now approved by the FDA," said Professor Jörg Kreuzer, vice president medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. Singapore: Global pharmaceutical company, Boehringer Ingelheim, has recieved USFDA approval for Praxbind (idarucizumab), indicated for patients treated with Pradaxa (dabigatran etexilate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |