FDA approved First Factor Xa Inhibitor Antidote

An estimated 4 million people are taking factor Xa inhibitors, such as rivaroxaban (Xarelto, Bayer/Janssen Pharmaceuticals) and apixaban (Eliquis, Bristol-Myers Squibb). In the USA, Apixaban generated 4.9 billion dollars for the company last year.

Until now, there was no approved reversal agent for these factor Xa inhibitors.

In the United States alone, there were approximately 117,000 hospital admissions attributable to factor Xa inhibitor-related bleeding and nearly 2000 bleeding related deaths per month.

Following is the dosing information.

It comes with a  boxed warning for thromboembolic risks, ischemic risks, cardiac arrest, and sudden death.

The most common adverse reactions in at least 5% of patients receiving the drug were urinary tract infections and pneumonia.

The approval is based on two trials, ANNEXA-R and ANNEXA-A, which demonstrated a median decrease in anti-factor Xa activity from baseline of 97% for rivaroxaban and 92% for apixaban.

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