Ondexxya (Andexanet alfa) | Relatório de avaliação de financiamento público disponível na Infomed | Deferimento do pedido de avaliação prévia Infarmed

Ondexxya (Andexanet alfa) | Relatório de avaliação de financiamento público disponível na Infomed | Deferimento do pedido de avaliação prévia
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#infarmed #medicamentos #financiamentopublico #ondexxya
#andexanetalfa

Zitatbild. Foto einer lächelnden Frau mit glattem braunem Haar. Text: „Die Kriterien für eine effektive Hämostase überzeugen uns nicht. Mehrere schwerwiegende Nebenwirkungen treten unter Andexanet alfa häufiger auf. Damit bleibt nur der Schluss, dass der Wirkstoff einen geringeren Nutzen hat als die Standardbehandlung.“ – Daniela Preukschat, Bereichsleiterin im IQWiG-Ressort Arzneimittelbewertung, 10/2025

#AndexanetAlfa bei #Hämorrhagie: Hoffnung hat sich nicht erfüllt

Eine auf Veranlassung der EMA durchgeführte vergleichende Studie zeigt ausschließlich negative Effekte.

Weitere Infos in unserer Pressemitteilung: www.iqwig.de/presse/press...

Zitatbild, Foto einer Frau mit glatten braunen Haaren. Text: „Die Kriterien für eine effektive Hämostase überzeugen uns nicht. Mehrere schwerwiegende Nebenwirkungen treten unter Andexanet alfa häufiger auf. Damit bleibt nur der Schluss, dass der Wirkstoff einen geringeren Nutzen hat als die Standardbehandlung.“ – Daniela Preukschat, Bereichsleiterin im IQWiG-Ressort Arzneimittelbewertung, 10/2025

#AndexanetAlfa bei #Hämorrhagie: Hoffnung hat sich nicht erfüllt

Eine auf Veranlassung der EMA durchgeführte vergleichende Studie zeigt ausschließlich negative Effekte.

Weitere Infos in unserer Pressemitteilung […]

[Original post on wisskomm.social]

Efficacy and safety of andexanet alfa for factor Xa inhibitor-associated intracranial haemorrhage Background Current international guidelines suggest andexanet alfa (AA) for the management of factor Xa inhibitor-associated intracranial haemorrhage (ICH). However, those recommendations are based on low-quality evidence and there is uncertainty regarding the net clinical benefit of AA. Methods We conducted a systematic review and meta-analysis including available randomised controlled clinical trials (RCTs) and observational studies that investigated efficacy and safety of AA compared with usual care for the treatment of factor Xa inhibitor-associated ICH. Good haemostatic efficacy, defined as haematoma expansion of ≤35% or ≤6 mL, was the primary outcome. Secondary efficacy outcomes were excellent haemostatic efficacy (≤20% haematoma expansion) and good functional outcome (modified Rankin Scale scores 0–3) at follow-up, while safety outcomes were mortality and thrombotic events at follow-up. Results Eighteen studies (1 RCT) were included comprising a total of 1567 patients treated with AA versus 1969 patients receiving usual care. AA was associated with a higher likelihood of good haemostatic efficacy (RR=1.16; 95% CI=1.06 to 1.26) compared with usual care, while excellent haemostatic efficacy (RR=1.04; 95% CI=0.85 to 1.26) and good functional outcome (RR=0.92; 95% CI=0.53 to 1.62) were similar between the two groups. Regarding safety outcomes, similar rates of mortality (RR=0.77; 95% CI=0.56 to 1.04) and thrombotic events (RR=1.20; 95% CI=0.81 to 1.78) were documented. Conclusions The present meta-analysis suggests AA is associated with improved haemostatic efficacy compared with usual care, with no significant differences observed in functional and safety outcomes. These findings indicate that AA may have a role in the management of factor Xa inhibitor-associated ICH, although further high-quality studies are needed to better define its net clinical benefit. All data relevant to the study are included in the article or uploaded as supplementary information.

Still a controversial topic: #andexanetalfa for #FXaInh reversal. More 💡 being shed here:

Thanks to @profmakris.bsky.social for invitation and editorial input and thank you to insightful, thoughtful reviewers who helped to improve the piece substantially. #andexanetalfa

DEFINE_ME

In light of the news from the FDA, we want to share this thoughtful Forum Article from Richard Buka, on the fate of #andexanetalfa in #rpthjournal

www.rpthjournal.org/article/S247...