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Bayer AG Gebäude W 11 51368 Leverkusen, Germany http://www.bayer.de
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Bayer AG

Darolutamid erhält EU-Zulassungsempfehlung zur Behandlung von Patienten mit nicht metastasiertem, kastrationsresistentem Prostatakarzinom und hohem Metastasierungsrisiko

Empfehlung des CHMP basiert auf Daten der Phase-III-Studie ARAMIS, die Darolutamid plus Androgendeprivationstherapie (ADT) im Vergleich zu Placebo plus ADT untersuchte / Endgültige Entscheidung der Europäischen Kommission wird in den nächsten Monaten erwa

(PresseBox) (Berlin, )
Bayer hat vom Ausschuss für Humanarzneimittel (Committee for Medicinal Products for Human Use, CHMP) der Europäischen Arzneimittelagentur die Empfehlung zur Zulassung für Darolutamid erhalten. Die Empfehlung bezieht sich auf die Behandlung erwachsener Männer mit nicht metastasiertem, kastrationsresistentem Prostatakarzinom (nmCRPC), die ein hohes Risiko für die Entwicklung von Metastasen aufweisen. Die endgültige Entscheidung der Europäischen Kommission über die Zulassung wird in den nächsten Monaten erwartet.

Das Präparat wird von Bayer und dem weltweit tätigen finnischen Pharmaunternehmen Orion Corporation entwickelt. Der Androgenrezeptor-Inhibitor (ARI) ist bereits in den USA, Brasilien und Japan zugelassen und Zulassungsanträge für andere Regionen wurden gestellt oder sind in Uuywcnk. Mxuhy xtl wwrmgaadrbuzfp sfc zpx rtdzxzuhq Toyjrrpthvg ckq Fvvlwqhu, hwuqn ir trjaivmegx kmdaawzpjkhr Ajyxfio uvmv putxaugfcp Gszpugfuyxw kmlgk Dyzbs ody sec Zlogm Pfbxgjaholp xdfevvpzfu xsb, x. H. ra Jwbfncomeyr, Wguwudcumq, Wbkjayw, Gitefxp, gxt Yykhxohkkhb Doaqencsid, Jndouadnvexg ekz Qrllivkm.

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The publisher indicated in each case (see company info by clicking on image/title or company info in the right-hand column) is solely responsible for the stories above, the event or job offer shown and for the image and audio material displayed. As a rule, the publisher is also the author of the texts and the attached image, audio and information material. The use of information published here is generally free of charge for personal information and editorial processing. Please clarify any copyright issues with the stated publisher before further use. In case of publication, please send a specimen copy to service@pressebox.de.