New Pradaxa antidote study preps Boehringer for market-share turnaround: ESC

LONDON--Boehringer Ingelheim's Pradaxa may have been first in its class of new-age anticoagulants to hit the scene, but since then, it's lost market share to Johnson & Johnson ($JNJ) and Bayer's contender, Xarelto. Bringing a bleeding antidote to market could give Pradaxa a boost, though, and Boehringer touted good news on that front Tuesday.

In 39 patients who required emergency surgery, the experimental drug, idarucizumab, reversed the effects of Pradaxa with a median 1.7 hours between administering of the drug and starting a procedure, a late-stage trial analysis shows. No bleeding complications turned up in the 24 hours after surgery, according to an interim analysis of the Phase III RE-VERSE AD trial. And doctors reported normal blood clotting during surgery for 92% of patients, Boehringer said.

Having a reversal agent in this population would help "get the concern off the physician's plate so that he or she can focus" on whatever else needs to happen in the emergency room," RE-VERSE AD lead investigator Charles Pollack told FiercePharma in an interview at the European Society of Cardiology Congress. "I think it's a game-changer for physicians."

All the new-age clot busters in Pradaxa's class--Xarelto, Bristol-Myers Squibb ($BMY) and Pfizer's ($PFE) Eliquis and newcomer Savaysa from Daiichi Sankyo--come along with bleeding risks, and the lack of an antidote has presented a hurdle to stealing market share from old-guard therapy warfarin, which has one. Some physicians have been hesitant to take up the new therapies for that reason, Pollack said, citing uncertainty of "'what to do if my patient bleeds.'"

A specific reversal agent, though, "may very well take some of that insecurity away," he noted--which has the potential to give Pradaxa a boost, both against the rivals in its class and against warfarin.

Whether it "will change prescribing patterns … once the drug is out there, we'll see what kind of impact it has," Pollack said.

While Boehringer's agent is primed to hit the market first--it's got a fast-track nod from the FDA, so it should see a decision by October--it's not the only company working on an antidote. Portola Pharma has been testing andexanet alfa with Eliquis and Xarelto, and it expects to file for FDA approval by the end of this year.

- see the release from Boehringer

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