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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

i studi clinici di fase 3, GEMINI I, GEMINI II, GEMINI III e  GEMINI LTS (Long-term Safety, sicurezza a lungo termine), che sono parte dei GEMINI Studies™, un programma di ricerca che prevede quattro studi clinici mirati alla valutazione dell'efficacia e della sicurezza del vedolizumab sulla risposta clinica  e sulla remissione , nei pazienti affetti da MC e CU in atto, da moderata a grave, non responsivi ad almeno una delle terapie convenzionali o al trattamento con anti-TNFα.

"Con il suo meccanismo d'azione mirato, il vedolizumab si accredita come potenziale opzione di trattamento clinico per i pazienti affetti da MC e CU in atto, da moderata a grave," ha dichiarato Paul Rutgeerts, MD, PhD, FRCP, Professore di Medicina presso l'Università Cattolica di Lovanio, in Belgio. "Benché non sia nota alcuna cura, c'è necessità di nuove opzioni di trattamento per MC e CU, nel tentativo di fornire ai pazienti ulteriori mezzi per gestire la malattia, attenuarne i sintomi e raggiungere la remissione".

Malattia di Crohn e colite ulcerosa

La malattia di Crohn (MC) e la colite ulcerosa (CU) sono le due forme più comuni di malattia infiammatoria cronica intestinale (MICI). Sono caratterizzate da infiammazione dello strato mucoso del tratto gastrointestinale. La MC può interessare qualsiasi parte del tratto digerente. Sintomi comuni possono essere dolore addominale, diarrea, sanguinamento rettale, perdita di peso e/o febbre. La CU interessa esclusivamente l'intestino crasso che comprende il colon e il retto. I sintomi più comuni della CU comprendono disturbi addominali e diarrea con presenza di muco o sangue. Benché l'eziologia di MC e CU non sia nota, molti ricercatori ritengono che l'innesco della malattia sia da addebitarsi all'interazione tra un agente esterno, virale o batterico, e il sistema immunitario. Non esistono terapie risolutive per MC e CU. Scopo dei t
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