Saturday, October 17, 2015

Praxbind (Idarucizumab)

Praxbind approved for specific emergency situations
FDA News Release - October 16, 2015
"The U.S. Food and Drug Administration today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects."
"On 24 September 2015, the committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Praxbind, a specific reversal agent for dabigatran, intended for use when rapid reversal of the anticoagulant effects of Pradaxa (dabigatran etexilate) is required in adult patients..."
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission."
1 Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion