21/7/2020
H Φαρμακευτική εταιρεία BIOGEN σχεδιάζει να ξεκινήσει μελέτη φάσης 4 αξιολογώντας το όφελος του SPINRAZA® (NUSINERSEN) σε ασθενείς που έχουν λάβει το ZOLGENSMA® (ONASEMNOGENE ABEPARVOVEC)
Σήμερα η Φαρμακευτική Εταιρεία — Biogen Inc. ανακοίνωσε ότι σχεδιάζει να ξεκινήσει παγκόσμια κλινική μελέτη φάσης 4, τη μελέτη RESPOND, για να εξετάσει το κλινικό όφελος και να αξιολογήσει την ασφάλεια του SPINRAZA® (nusinersen) σε νεογνά έως 9 μηνών και παιδιά έως 3 χρόνων που έχουν λάβει το γονιδιακό φάρμακο το Zolgensma® (onasemnogene abeparvovec) (60 συνολικά συμμετέχοντες). Η εταιρεία σκοπεύει να καταθέσει το Πρωτόκολλο της μελέτης στις Ρυθμιστικές Αρχές τους επόμενους μήνες, ώστε να ξεκινήσει εντός του πρώτου τετραμήνου του 2021.
Περισσότερες λεπτομέρειες θα βρείτε στο δελτίο τύπου της Εταιρείας:
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