Janssen (NYSE:JNJ) has announced that its blockbuster blood thinner Xarelto (rivaroxaban) had a similar safety profile to aspirin in pediatric patients a Phase 3 study. The trial focused on pediatric patients who underwent the Fontan procedure, a type of open-heart surgery intended to correct single ventricle anomalies in the heart.
Physicians have traditionally relied on aspirin (acetylsalicylic acid) to reduce the risk of thrombotic events following the Fontan procedure. Such thrombotic events are associated with significant morbidity and mortality.
The data, collected in the Phase 3 UNIVERSE trial, has been published in the Journal of the American Heart Association. The study concluded that “participants who received rivaroxaban for thromboprophylaxis [thrombosis prevention] had a similar safety profile and fewer thrombotic events, albeit not statistically significant, compared with those in the [acetylsalicylic acid] group.”
This summer, the Raritan,…