Portola will finally see the commercial release of its universal bleeding reversal agent Andexxa, a milestone not only for the biotech but also for Pfizer and Bristol-Myers Squibb, as well as Bayer and Johnson & Johnson, whose blood thinners rely on it as a bleeding antidote.
The FDA this week approved Portola Phamaceutical’s second-generation Andexxa after being delayed more than two years because of concerns about its large-scale production processes. The agency approved the drug last spring but only allowed Portola to offer clinical supplies while the company tested its commercial production methods. As a result, the company had to limit supplies to about 1,000 healthcare providers.
“It is clear from the response to the Andexxa Early Supply Program that there is significant need for a specific reversal agent that can address life-threatening bleeding associated with the use of the Factor Xa inhibitors apixaban and rivaroxaban,” Scott Garland said in a statement. Garland became Portola CEO in September, replacing Bill Lis who retired after 10 years with the company. "We are pleased to now be able to stock hospitals nationwide and serve all patients in the U.S. who could benefit from the potential life-saving impact of Andexxa.”
The company said it will offer more details about the launch during a webcast on Tuesday, Jan. 8. Portola initially placed the wholesale price of the drug at $27,500.
The commercial availability of Andexxa has been eagerly anticipated by a foursome of major pharma players whose popular blood thinners have no antidote for excessive bleeding. Andexxa will serve as reversal agent for Johnson & Johnson’s Xarelto and Bristol-Myers Squibb and Pfizer’s Eliquis. The availability of Andexxa will help in their competition with Boehringer Ingelheim, whose blood thinner Pradaxa had a bleeding reversal agent approved in 2015.
Pfizer and Bristol-Myers were so anxious to see the bleeding antidote reach the market that when Portola was hit with a complete response letter in August 2016 over manufacturing questions, they kicked in $50 million in unsecured loans to help Portola get to the finish line with the treatment.
The approval also reduces the risk of litigation that has mounted against the companies as a result of uncontrolled bleeding in patients, the major complication of anticoagulants.
The new generation of blood thinners have been popular because of their benefits compared to enoxaparin and warfarin in preventing and treating strokes, pulmonary embolisms and venous thromboembolism (VTE). But Portola pointed out that because of their increased use, deaths and hospitalizations tied to them have also grown. Hospital admissions attributable to Factor Xa inhibitor-related bleeding reached 140,000 in 2017, the company said. That was up from an estimated 117,000 incidents the year before.