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Takeda presenta la richiesta di autorizzazione all'immissione in commercio nell'Unione Europea per Vedolizumab nella colite ulcerosa moderata-grave e nella malattia di Crohn
Date:3/8/2013

Osaka, Giappone, March 8, 2013 /PRNewswire/ --

Takeda Pharmaceutical Company Limited ("Takeda") ha annunciato oggi di aver presentato una richiesta di Autorizzazione all'Immissione in Commercio (AIC) all'Agenzia europea per i medicinali (EMA - European Medicines Agency) per il vedolizumab, un anticorpo monoclonale umanizzato a selettività intestinale in fase sperimentale, destinato al trattamento della malattia di Crohn (MC) e della colite ulcerosa (CU) moderata-grave, le due  malattie infiammatorie intestinali croniche (MICI) più comuni. Se approvato, il vedolizumab potrebbe rappresentare il primo e unico agente biologico a selettività intestinale attualmente sul mercato per le MICI.

"La colite ulcerosa e la malattia di Crohn sono due malattie croniche debilitanti, con notevoli esigenze mediche insoddisfatte, che colpiscono sovente soggetti giovani, nel fiore degli anni", ha dichiarato Asit Parikh , MD, Ph.D, Vice President, General Medicine di Takeda. "Ci incoraggiano i risultati di GEMINI, il programma di sviluppo clinico di fase 3 del vedolizumab, che ha coinvolto circa 3.000 pazienti in quasi 40 Paesi, accreditandosi come il più esteso programma di trial clinico rivolto alle MICI finora realizzato."

In tutto il mondo, sono quasi quattro milioni i pazienti affetti da MICI. Di questi, nell'Unione Europea, più di 500.000 sono affetti da CU e quasi 230.000 da MC. La malattia di Crohn e la colite ulcerosa sono malattie croniche, che determinano l'infiammazione della mucosa del tratto digerente. Mentre lo stato infiammatorio prodotto dalla MC può coinvolgere aree diverse del tratto digerente, la CU colpisce esclusivamente il colon-retto. MC e CU possono essere dolorose e debilitanti, generare complicanze gravi e incidere significativamente sulla qualità di vita dei pazienti.

La presentazione dell'AIC è stata supportata dai risultati degl
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SOURCE Takeda Pharmaceutical Company Limited
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