Active ingredient: andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo]
Disease: Factor Xa bleeding antidote
Peak sales estimate: $500 million to $700 million
Approved: May 3, 2018
Company: Portola Pharmaceuticals
The scoop: After a rejection letter from the FDA brought its plans to a standstill, Portola and its contractor spent over a year developing a new manufacturing process for Andexxa that would pass agency muster. The drug’s accelerated approval in May made it the first antidote for uncontrolled bleeding in patients taking blood thinners like Johnson & Johnson’s Xarelto (rivaroxaban) or Bristol-Myers Squibb and Pfizer’s Eliquis (apixaban).
That’s a big market; With more than 117,000 hospitalizations for related bleeding in 2016 and a wholesale price of $27,500, Andexxa could have blockbuster potential. It could also help boost Xarelto and Eliquis’ sales as well—so much so that Pfizer and BMS loaned Portola $50 million to recover after the drug received its CRL.
So far, Andexxa’s rollout has been limited to a few treatment centers as Portola waits for a final FDA greenlight on its new large-scale manufacturing process, expected in the first quarter of next year. — Conor Hale