“Today’s approval represents a significant step forward in patient care and one that the medical community has been eagerly anticipating,” Stuart J. The drug is now indicated as an antidote for rivaroxaban and apixaban when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
orphan drug and FDA breakthrough therapy designations after it was shown to change baseline anti-Factor Xa activity in healthy volunteers. hospitalizations for Factor Xa-related bleeding in 2016 and nearly 2,000 deaths per month.Īndexxa received U.S. According to Portola’s press release, there were approximately 117,000 U.S.
The FDA has approved the use of Andexxa, the first reversal agent for Factor Xa inhibitors, drug manufacturer Portola Pharmaceuticals announced May 3.įactor Xa inhibitors are growing in popularity due to their ability to prevent and treat thromboembolism, but those drugs are also associated with a risk of bleeding events.
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