Reversal agents could unclot the NOAC market
- German drugmaker Boehringer Ingelheim on Tuesday continued to build out the evidence base supporting its reversal agent Praxbind (idarucizumab), unveiling updated data from a Phase 3 real-world study which showed the antidote quickly reversed the anticoagulant effects of the company's Pradaxa (dabigitran).
- While the vitamin K antagonist warfarin remains a trusted blood-thinner, new oral anticoagulants (NOACs) from Boehringer, Bristol-Myers Squibb and Johnson & Johnson are gathering steam.
- Yet so far Praxbind remains the only antidote approved for NOACs in the U.S., and only works to reverse the effects of Pradaxa. Portola Pharmaceuticals is pushing ahead with AndexXa, a universal Factor Xa inhibitor antidote, but has so far been stymied at the FDA.
Anticoagulants, or blood thinners, are lifesavers for people at risk of stroke or blood clots. A number of NOACs have been developed in recent years, boasting better safety and efficacy than warfarin, which remains a cheaper and trusted anticoagulant.
Bristol-Myers' Eliquis (apixaban) and Johnson & Johnson's Xarelto (rivaroxaban), both Factor Xa inhibitors, have led the way, pulling in billions of sales. There are no approved antidotes for Factor Xa inhibitors, however, likely holding back sales and tilting the risk-benefit scales for some patients in favor of warfarin.
Boehringer hopes Praxbind, which was approved in October 2015, can help boost sales of Pradaxa and give it an edge over competing NOACs like Eliquis and Xarelto.
According to results from the RE-VERSE AD trial, Praxbind reversed anticoagulant effects in 100% of patients treated with Pradaxa who presented to a hospital with life-threatening bleeding or needed emergency surgery.
Boehringer competitive edge was boosted earlier this year when the Food and Drug Administration turned down Portola's application for approval of AndexXa. While Portola believes it can resolve the issues, Pradaxa could remain the only NOAC with an approved reversal agent for some time.
At the same time, Portola is moving forward with its own Factor Xa inhibitor betrixaban. New substudy results from the Phase 3 APEX trial were unveiled this week at the American Heart Association meeting in New Orleans. According to the data, betrixaban reduced the risk of all-cause stroke and ischemic stroke in hospitalized medically ill patients, compared to enoxaparin.
Portola submitted betrixaban for FDA approval last month, aiming to market the drug for prevention of venous thromboembolism in acute medically ill patients.
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