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Merck KGaA Frankfurter Straße 250 64293 Darmstadt, Germany http://www.merck.de
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Merck KGaA

Merck erhält Zulassungsempfehlung für Kuvan® in Europa

Ausschuss für Humanarzneimittel (CHMP) empfiehlt Marktzulassung von Kuvan® zur Behandlung der Hyperphenylalaninämie bei Patienten mit Phenylketonurie oder BH4-Mangel

(PresseBox) (Darmstadt, )
Die Merck KGaA und ihre Sparte Merck Serono haben heute bekannt gegeben, dass der Ausschuss für Humanarzneimittel CHMP (Committee for Medicinal Products for Human Use) der Europäischen Arzneimittelagentur EMEA eine positive Stellungnahme für Kuvan® (Sapropterindihydrochlorid) zur oralen Therapie der Hyperphenylalaninämie (HPA) bei Patienten mit Phenylketonurie (PKU) oder Mangel an Tetrahydrobiopterin (BH4) abgegeben hat.1 Mit dieser positiven Stellungnahme empfiehlt das CHMP die Marktzulassung von Kuvan® durch die Europäische Kommission. Kuvan® hatte zuvor von der EMEA für die Behandlung der HPA den Status eines "Orphan Medicinal Product", eines neuen Arzneimittels zur Behandlung seltener Krankheiten, erhalten.

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