FIREFISH is a 2-part, open-label study of Evrysdi in 62 infants aged 2 to 7 months with Type 1 SMA. Part 1 explored the dose and safety of Evrysdi in 21 infants. Part 2 measured the effectiveness and safety of Evrysdi in 41 infants. Fifty-eight infants aged 2 to 7 months who received the recommended dose of Evrysdi in Parts 1 and 2 were included in a pooled analysis.
BSID-III stands for Bayley Scales of Infant and Toddler Develoment-Third Edition.
BSID-III stands for Bayley Scales of Infant and Toddler Development–Third Edition. HINE-2 stands for Hammersmith Infant Neurological Examination–Module 2.
The Bayley Scales of Infant and Toddler Development–Third Edition (BSID-III) is a gross motor scale that assesses a range of physical abilities such as sitting, rolling, and crawling.
The Hammersmith Infant Neurological Examination–Module 2 (HINE-2) assesses 8 developmental milestones for infants, including head control, sitting, voluntary grasp, ability to kick, rolling, crawling, standing, and walking.
“Evrysdi has been the right decision for our family. Kayden has just had a wonderful response.”
*Permanent support was defined as having a tracheostomy (a surgery where a tube is inserted in the front of the throat into the windpipe) or more than 21 days of either noninvasive ventilation support (16 or more hours a day) or being intubated (a procedure where a breathing tube is inserted down the throat and into the windpipe) to help with breathing, in the absence of an acute reversible event.
*Includes infants who could eat by mouth or in combination with a feeding tube.
†One infant could not swallow at the start of the study.
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Información de prescripción de Evrysdi® (risdiplam). Genentech, Inc.
Información de prescripción de Evrysdi® (risdiplam). Genentech, Inc.
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