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FDA sagt Sitzung des Beratergremiums zu Icatibant ab

Beschleunigtes Verfahren wird fortgesetzt

(PresseBox) (Berlin, )
Die Jerini AG (FSE:JI4) gab heute die Entscheidung der amerikanischen Gesundheitsbehörde FDA (Food and Drug Administration) bekannt, die für den 20. Februar geplante Sitzung des "Pulmonary-Allergy Drugs Advisory Committee" ausfallen zu lassen.

Diese Sitzung sollte ursprünglich ein Forum für FDA-Berater bieten, die Daten des Zulassungsantrags für Icatibant zur Behandlung des hereditären Angioödems (HAE), einer Krankheit, für die es in den USA derzeit kein zugelassenes Medikament gibt, zu diskutieren. Wie die FDA dem Unternehmen mitteilte, sei ein Treffen des Beratergremiums nicht mehr erforderlich; die Prüfung des Antrags innerhalb eines beschleunigten Verfahrens werde fortgesetzt.

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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.