Last year, Boehringer Ingelheim’s Pradaxa picked up an edge on its new-age anticoagulant rivals when the FDA approved a reversal agent. Now, the agency has turned back an antidote to blockbuster rivals Xarelto and Eliquis--and that means the German drugmaker is set to hang onto that safety advantage.
Wednesday, South San Francisco’s Portola Pharmaceuticals announced the FDA had handed down a complete response letter for AndexXa, the experimental med designed to reverse the effects of Johnson & Johnson’s Xarelto, Bristol-Myers Squibb and Pfizer’s Eliquis, and Daiichi Sankyo’s Savaysa--a.k.a., all of Pradaxa’s next-gen competitors.
And the delay could be long enough to make a difference. Before the Portola agent continues its journey toward approval, the agency wants to see more information, particularly about the med's manufacturing. And if use with Savaysa is going to make its way onto AndexXa’s label, the FDA will need more data to support its inclusion, too.
“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 Thursday call, noting that “it will require a meeting” with regulators “to understand it better.”
Meanwhile, Pradaxa--for which reversal agent Praxbind was green-lighted in October--is sitting pretty. Unlike its nemeses, BI boasts a tool for managing anticoagulant patients in emergency or life-threatening situations when bleeding can’t be controlled.
That bleeding risk--and the absence of an antidote--had kept doctors loyal to old-guard therapy warfarin, despite its more difficult dosing and requirements for ongoing monitoring. BI is hoping that as Praxbind picks up steam, doctors will feel more secure with Pradaxa.
It’s also hoping its first-to-market med can regain some of the ground it lost when fast-mover Xarelto hit the scene. Eliquis, which got off to an ice-cold start, has recently ratcheted up the pace, too, thanks to investments in DTC and other marketing.
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