FDA Approves Large-Scale Production of Andexxa
December 31, 2018 – The U.S. FDA has approved Portola Pharmaceutical’s application for large-scale, second generation Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo], allowing a nationwide launch of the product. Although granted accelerated FDA approval in May 2018, Andexxa distribution was limited due to FDA concerns regarding large-scale manufacturing.
Andexxa is indicated to reverse the anticoagulation effects of rivaroxaban or apixaban in the event of life-threatening or uncontrolled bleeding. Rivaroxaban and apixaban are factor Xa anticoagulants used to prevent serious adverse events, such as strokes, caused by blood clots.
In 2018, Factor Xa inhibitor related bleeding events accounted for approximately 140,000 hospital admissions. Through an Early Supply Program, Portola provided Andexxa to approximately 1,000 healthcare providers while testing its commercial production methods. It will now be able to offer Andexxa throughout the United States.
A black box warning cautions that Andexxa is associated with thromboembolic risks, ischemic risks, cardiac arrest, and sudden death. Recommended dosing depends on specific patient factors.
The current wholesale acquisition cost (WAC) for Andexxa is $22,000 for four vials of the 200mg dosage strength, and $11,000 for four vials of the 100mg dosage strength. Recommended dosing is based on several patient factors.