NOACs offer convenient fixed dosing without need for routine coagulation monitoring and they have predictable pharmacokinetics, fewer interactions and quicker onset (and offset) of action than warfarin. Warfarin can be rapidly reversed but, until now, NOACs have no validated reversal strategies which could compromise the clinical outcome. Specific antidotes to NOACs have recently been developed or are in current development. Three products of potential interest were identified.
_ Idarucizumab is currently available to reverse the anticoagulant effects of dabigatran.
_ Andexanet alpha is being developed (for potential launch in 2017) to reverse the anticoagulant effects of rivaroxaban, apixaban and potentially edoxaban.
_ Aripazine (PER977) is being developed (currently in phase 2 studies) as a universal antidote to reverse the anticoagulant effect of NOACs, oral factor Xa inhibitors, fondaparinux, LMWH’s and unfractionated heparins.
This briefing aims to provide an update on these products, including the evidence base underpinning their use, which may be licensed as antidotes to NOACs now or in the relatively near future.
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Regional Medicines Information Manager, London Medicines Information Service