Praxbind: animal efficacy model or human cells?

“The rat tail bleeding model represents a situation with limited blood loss. Also the intracranial haemorrhage in mice is associated with limited bleeding. In contrast, the pig liver trauma model is associated with severe blood loss, haemorrhagic shock and ultimately mortality.”

“As it is difficult to obtain controlled information from humans treated in emergency situations, these non-clinical PD studies were considered justified and the results were adequately reflected in section 5.1 of the SmPC.”

“The pharmacology of idarucizumab was adequately demonstrated in vitro. Idarucizumab binds with high affinity to dabigatran and thereby blocks the anti-coagulant activity of dabigatran in human plasma. Absence of idarucizumab binding to other thrombin substrates and lack of pro-thrombotic activity was sufficiently demonstrated as considered by the CHMP.”