The first and only reversal agent indicated for patients being treated with rivaroxaban (Xarelto, Janssen) and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding, has been approved by the FDA.
Coagulation factor Xa (recombinant), inactivated-zhzo (Andexxa, Portola received both U.S. Orphan Drug and FDA Breakthrough Therapy designations. It was approved under FDA’s Accelerated Approval pathway, based on the change from baseline in anti-factor Xa activity in healthy volunteers.
"Today's approval represents a significant step forward in patient care and one that the medical community has been eagerly anticipating. Andexxa's rapid reversal of the anticoagulating effects of rivaroxaban and apixaban will help clinicians treat life-threatening bleeds, where every minute counts,” says Stuart J. Connolly, MD, executive committee chairman of an Andexxa clinical trial and professor in the Department of Medicine of the Faculty of Health Sciences at McMaster University in Hamilton, Ontario, in a statement.
To find out more about this novel antidote, Drug Topics spoke with a Portola spokesperson.
Drug Topics: Why is the approval of Andexxa so significant?
Portola: We believe Andexxa represents a major advance for patients, with the potential to save lives. The unmet medical need and the number of patients admitted to the hospital with Factor Xa-inhibitor-related bleeding is significant and continues to grow. In 2016, there were approximately 117,000 hospital admissions in the U.S. and nearly 2,000 deaths attributable to Factor Xa inhibitor-related bleeding. Andexxa's rapid reversal of the anticoagulating effects of rivaroxaban and apixaban will help clinicians treat life-threatening bleeds, where every minute counts. For context, patients with the most severe life-threatening bleeds have 30-day mortality rates of up to 40% with an average hospital stay of 10 days or more, and the cost to manage these patients in the hospital exceeds $100,000.
Drug Topics: When will Andexxa be available on the market?
Portola: We expect to launch Andexxa in early June through an Early Supply Program with Generation 1 product. Through this program, we will be offering Andexxa to a limited number of hospitals (30 to 40) that are predominantly sites that took part in the ANNEXA-4 clinical trials, and a limited number of level 1 trauma and comprehensive stroke centers. This limited launch will allow us to leverage the relationships and experience of our clinical trial sites to reach some of the highest-risk patients, and importantly, to serve as a bridge for the Generation 2 drug supply. We’re anticipating a broader commercial launch in early 2019 upon FDA approval of the Generation 2 manufacturing process for Andexxa.
Drug Topics: What is the wholesale acquisition cost of Andexxa?
Portola: The wholesale acquisition cost in the U.S. will be $27,500 per gram, which approximates the average per patient dose. The price of Andexxa reflects its novel attributes, as well as its Orphan Drug Designation and the targeted population of high-risk patients who will benefit from the use of Andexxa.