Earlier this month, Portola Pharmaceuticals took a hit when the FDA swatted down its reversal agent candidate for next-gen anticoagulants–and the makers of those anticoagulants did, too. But Tuesday, the company unveiled some solid data that may help soften the blow.
In interim results presented at the European Society of Cardiology’s annual meeting in Rome, Portola’s prospect–AndexXa–“rapidly and substantially” reversed the effects of new-age clot-busters in patients for whom the drug had triggered major bleeding. And following infusion, 79% of patients saw a bleeding stoppage researchers dubbed “excellent” or “good” over a 12-hour period.
Patients receiving Johnson & Johnson’s Xarelto experienced an 89% decrease in anti-Factor Xa activity following their AndexXa dose, while those on Bristol-Myers Squibb and Pfizer’s Eliquis saw activity sink by a median 93%, Portola said.
It’s good news for Portola, J&J and the BMS/Pfizer team, who are all playing catch-up in the antidote department to Boehringer Ingelheim. Last October, the German drugmaker won FDA approval for Praxbind, a reversal agent specific to its own anticoagulant, Pradaxa–giving Pradaxa a market advantage that Xarelto and Eliquis can’t boast.
While Xarelto maintains the market lead, Johnson & Johnson would certainly like to have a reversal agent in hand to help shore up its position. And an approval for AndexXa would help Eliquis–which is mounting a comeback after an ice-cold start–too.
The companies may have awhile to wait, though. Earlier this month, South San Francisco-based Portola announced that the FDA had handed down a complete response letter for AndexXa, with regulators requesting more information–particularly about the candidate’s manufacturing.
“I think the challenge we face now is we’re trying to understand many of the FDA’s questions here,” Portola CEO William Lis told investors on a conference call, noting that “it will require a meeting” with regulators “to understand it better.”