1 October 2025 - A comparative study conducted at the instigation of the EMA shows only negative effects.

If life-threatening or uncontrollable bleeding occurs during treatment with an anticoagulant, the effect of the anti-coagulant must be reversed as quickly as possible. The active ingredient andexanet alfa has been available for anticoagulation with rivaroxaban or apixaban since 2019 and was perceived as promising at the time. However, an initial early benefit assessment lacked comparative study data, so the conclusion was additional benefits not proven. The Federal Joint Committee (G-BA) issued a temporary decision. Following the expiration of the temporary period, AstraZeneca has now submitted a new dossier, this time containing meaningful data from a trial commissioned by the EMA.

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