Cosmo Pharmaceuticals gibt kurze Verlängerung des FDA Untersuchungszeitraums für das NDA von BYFAVO™, einem ultra kurz agierenden und reversiblen Anästhetikum für prozedurale Sedierung bekannt Donnerstag, 12. März 2020 - 12:50

Dublin, Irland – 12. März, 2020 - Cosmo Pharmaceuticals N.V. (SIX: COPN) gab heute bekannt, dass die US Food and Drug Adiministration (FDA) den Untersuchungszeitraum für den Zulassungsantrag (NDA) von BYFAVO™ (Remimazolam) um bis zu 90 Tage verlängert hat, um die Überprüfung von zusätzlichen Daten, die im Januar und Februar eingereicht wurden, abschliessen zu können.

Die FDA hat ein neues „Prescription Drug User Fee Act“ (PDUFA) Ziel für die Bearbeitung und Entscheidung auf spätestens 5. Juli 2020 festgesetzt (bisher 5. April 2020).

Acacia Pharma hat die US-Rechte an BYFAVO™ von Cosmo im Januar 2020 einlizensiert.

About BYFAVO™

BYFAVO™ (Remimazolam) is an ultra-short-acting and reversible intravenous benzodiazepine sedative/anesthetic designed for use during invasive medical procedures, such as during colonoscopy and bronchoscopy. Approximately 24.5 million such procedures take place annually in the US, of which around 90% use moderate sedation.

BYFAVO™ has demonstrated efficacy and safety in an extensive clinical trial programme involving around 2,400 volunteers and patients. Data so far indicate that Remimazolam has a rapid onset and offset of action combined with a good cardio-respiratory safety profile. BYFAVO™ is designed to act more quickly than the available alternatives of the same pharmaceutical class for the same indication (e.g. midazolam) and can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary.

Cosmo in-licensed the US rights to BYFAVO™ from Paion AG in 2016 and together they have progressed the product candidate through to registration. The NDA for BYFAVO™ has been filed with the US FDA in April 2019 and the new target PDUFA action date is 5 July 2020.

Über Cosmo Pharmaceuticals

Cosmo ist ein spezialisiertes Pharmaunternehmen, das sich auf die Behandlung ausgewählter gastrointestinaler Krankheiten und die Unterstützung in der Endoskopie konzentriert. Die firmeneigene klinische Entwicklungspipeline des Unternehmens befasst sich speziell mit innovativen Therapien für IBD, Dickdarminfektionen und die Erkennung von Dickdarmverletzungen. Aemcolo wurde kürzlich für die USA an Red Hill Biopharma auslizensiert. Cosmo hat auch Medizinprodukte für die Endoskopie entwickelt und ist kürzlich eine Partnerschaft mit Medtronic für den weltweiten Vertrieb seines neuartigen Gerätes im Bereich der Künstlichen Intelligenz eingegangen, welches in Koloskopien und GI-Verfahren verwendet werden soll. Darüber hinaus ist Cosmo Lizenznehmer für die USA für den neuartigen Wirkstoff zur prozeduralen Sedierung, Remimazolam, und hat diesen kürzlich an Acacia unterlizensiert. Für weitere Informationen über Cosmo und die Produkte besuchen Sie bitte die Website des Unternehmens: www.cosmopharma.com

Kalender

Kontakt:

Niall Donnelly, Chief Financial Officer & Head of Investor Relations

Cosmo Pharmaceuticals N.V.

Tel: +353 1 817 03 70

ndonnelly@cosmopharma.com

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