EMA Advisory Committee Recommends BI’s Anticoagulant Related Drug
The Committee for Medicinal Products for Human use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending European approval of idarucizumab (to be marketed as Praxbind) for adult patients treated with Pradaxa (dabigatran etexilate) when rapid reversal of its anticoagulant effects is required for emergency surgery / urgent procedures or in life-threatening or uncontrolled bleeding.
Idarucizumab is currently being reviewed for approval by regulatory authorities worldwide, including the US FDA. Boehringer Ingelheim plans to submit idarucizumab in all countries where dabigatran is licensed.
Idarucizumab was discovered and developed by Boehringer Ingelheim scientists. The research program was initiated in 2009, before dabigatran (Pradaxa) was launched in the US in 2010.
Idarucizumab is a humanized antibody fragment, or Fab, designed as a specific reversal agent to dabigatran. Idarucizumab binds specifically to dabigatran molecules only, neutralizing their anticoagulant effect without interfering with the coagulation cascade.
Source: Boehringer Ingelheim