In patients taking anticoagulants it is essential to be able to act quickly in cases where potentially fatal bleeding develops or which could have important consequences, such as intracranial bleeding. Now, a post-marketing Phase IV study of the drug andexanet alfa, used to treat intracranial bleeding from direct-acting oral anticoagulants (DOACs), has been halted early due to reaching its target predefined criteria of superior hemostatic efficacy compared to current therapeutic strategies.
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The drug-antidote
Andexanet alfa is the first antidote specifically designed to rapidly reverse the anticoagulant effects of direct oral factor Xa inhibitors in life-threatening or uncontrolled bleeding. The treatment is already approved in the European Union, Switzerland and the United Kingdom for adults treated with the factor Xa inhibitors apixaban and rivaroxaban, and has received accelerated approval in the United States. In Italy it is authorized for hospital use and is currently being evaluated by the Aifa drug agency for reimbursement. The use of andexanet alfa is recommended by more than 15 national and international guidelines in many fields.
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Early termination of the study
The decision to stop the study, called ANNEXA-I, was recommended by the Data and Safety Monitoring Board (DSMB) following a protocol-mandated interim efficacy assessment, which showed the reversal benefits of andexanet alfa after 450 patients were randomized and followed up for one month, earlier than originally anticipated in study enrollment. “We are pleased that the ANNEXA-I study met its efficacy goal at the predefined interim analysis, showing that andexanet alfa provides better bleeding control with targeted reversal of anticoagulation compared to standard treatment,” comments Danilo Toni, Full Professor of Neurology, Past President of the Italian Stroke Association, Director of the Neurovascular Treatment Unit at the Umberto I Policlinico Department of Human Neurosciences, La Sapienza University, Principal Investigator of the study in Italy”.
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Towards a change in clinical practice
Anticoagulants are used in many cardiovascular conditions, for example to prevent venous thromboembolism, pulmonary embolism, strokes, heart attacks when there are occlusions of the arteries. “The benefits shown in terms of haemostatic efficacy in patients treated with direct-acting oral anticoagulants (DOACs), who develop life-threatening bleeding or with a strong impact on their quality of life, underline the potential of andexanet alfa to change clinical practice – concludes Toni – We are eager to share the complete efficacy and safety results, with the hope that these data pave the way for new indications on the treatment of life-threatening bleeding”.
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