Boehringer trials Pradaxa anti-bleeding antidote
pharmafile | December 11, 2014 | News story | Sales and Marketing | BMS, Bayer, Boehringer, Eliquis, Pradaxa, ash, dabigatran, idarucizumab
Boehringer Ingelheim says that its investigational drug can safely reverse the blood-thinning effect of its anti-clotting drug Pradaxa (dabigatran).
The company presented data at the American Society of Hematology annual conference in San Francisco, which found that infusions of the investigational drug idarucizumab, which was granted breakthrough therapy status by the FDA in June, successfully reverses the anticoagulant effect of Pradaxa.
An antidote for Pradaxa and other new oral anticoagulants would be clinically useful in situations where they cause a patient to bleed too much or uncontrollably. Antidotes may also alleviate some of the safety concerns that have dogged Boehringer Ingelheim, which is facing lawsuits in the US after reports of severe and fatal bleeding.
The manufacturers of similar anticoagulants – Bayer and Janssen’s Xarelto (rivaroxaban), and Pfizer and BMS’ Eliquis (apixaban) – are working on other investigational drugs that can block the effects of anticoagulants in collaboration with Portola Pharmaceuticals
Bayer registered a Phase III study of an inhibitor drug, PRT4445, in February. BMS and Pfizer announced favourable Phase III results of its inhibitor drug Andexanet Alfa in November.
This is the first time that an antidote under development for a new anticoagulant is being investigated in a study in volunteers.
Idarucizumab was tested in healthy adults, elderly individuals and people with kidney impairment – characteristics that are common among patients who require anticoagulation – and was found to be safe and effective in all these groups, and no clinically relevant adverse events were reported.
Dr Georg van Husen, head of the cardiovascular therapeutic area at Boehringer Ingelheim, says:
“The growing evidence supports idarucizumab as a highly targeted antidote for dabigatran which can provide immediate, complete and sustained reversal. It would be an additional option for use in clinical situations where patients might benefit from a fast reversal of the anticoagulant effect of Pradaxa.”
In a separate study, also presented at the American Society of Hematology conference, researchers investigated the bleeding risks associated with new anticoagulants.
Their analysis compared the rates of major bleeding in ‘real-world’ patients with atrial fibrillation who began treatment with Pradaxa, Xarelto or warfarin. Dr Martin Ellis, from the Sackler School of Medicine at Tel Aviv University, says the results in clinical settings are consistent with those seen in company-led trials which found that the new anticoagulants have similar safety and efficacy in the real world as warfarin.
Dr Ellis says: “While our findings suggest that these new oral anticoagulants are safe, clinicians must remain vigilant about their use and screen patients for potential contraindications or high-risk features that may increase their likelihood of dangerous bleeding.”
Lilian Anekwe
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