Pradaxa – an anticoagulant developed by Boehringer Ingelheim – was the first in its class to receive FDA approval. Since its launch however, it has lost market share to a competitor drug, Xarelto, made by Johnson and Johnson in collaboration with Bayer.
Boehringer hopes that launching a specific reversal agent* to counteract the effects of the blood thinner may benefit sales of Pradaxa. The Phase III Reversal Effects of Idarucizumab on Active Dabigatrin (RE-VERSE AD) trial tested the effects of the experimental drug idarucizumab, on 39 patients who were admitted for emergency surgery.
The specific reversal agent* was able to reverse the effects of Pradaxa in an average time of just over 1.5 hours, between drug administration and commencement of the surgery. In addition, the study didn’t identify any cases of bleeding complications within 24 hours of surgery.
Surgeons noted that in 92% of patients treated with the experimental drug, blood was able to clot normally during the surgical procedure. The lead investigator in the RE-VERSE AD study, Charles Pollack, said that having the specific reversal agent* on-hand would help, “get the concern off the physician’s plate so that he or she can focus.” He went on to say, “I think it’s a game-changer for physicians.”
All of the blood thinners that belong to the same drug class as Pradaxa pose uncontrollable bleeding risks, which prevent any one pharmaceutical from gaining market share over other classes of anticoagulants. Pollack noted that physicians are wary of prescribing new anticoagulants because of the uncertainty they face of not knowing, “what to do if my patient bleeds.” Bristol-Myers Squibb and Pfizer’s Eliquis, along with Daiichi Sanko’s Savaysa, and the aforementioned Xarelto, are all anticoagulants that lack an antidote.
The leading anticoagulant on the market is warfarin, due in part to the availability of a compatible antidote. Following the positive results of the RE-VERSE AD trial, Pradaxa may just give warfarin – along with the other anticoagulants – a run for its money.
Pollack predicts that the availability of idarucizumab, “may very well take some of that insecurity away.” He went on to say that it, “will change prescribing patterns … once the drug is out there, we’ll see what kind of impact it has.”
While Boehringer’s idarucizumab has received fast track status by the FDA, it’s not the only pharmaceutical developer working on a specific reversal agent*. Andexanet alfa – an antidote developed by Portola Pharma – is currently in trials to test its effectiveness against Eliquis and Xarelto.
*Updated September 10, 2015 – “Bleeding antidote” replaced with “specific reversal agent” for accuracy.
- New Pradaxa antidote study preps Boehringer for market-share turnaround: ESC – http://www.fiercepharmamarketing.com/story/new-pradaxa-antidote-study-preps-boehringer-market-share-turnaround-esc/2015-09-02