New Four Year Data For Roche's Evrysdi Reinforces Long-Term Efficacy, Safety Profile In Muscular Atrophy Patients

Roche Holdings AG (OTC:RHHBY) announced new long-term data for Evrysdi (risdiplam) in a broad range of people aged 2-25 years with spinal muscular atrophy (SMA) from the pivotal SUNFISH study.
Data confirm that increases in motor function were sustained at four years, and the overall rate of adverse events continued to decrease over the 48 months, reinforcing the long-term efficacy and safety of Evrysdi.
Participants also reported continuous improvement or stabilization when independently performing activities of daily living such as eating, drinking, and picking up and moving objects.
The increase in motor function from baseline observed during the first year of the study was maintained through the fourth year of treatment with Evrysdi.
Without treatment, natural history data show that patients with Type 2 or 3 SMA typically show a decline in motor function over time.
Evrysdi was well-tolerated over the four years. Adverse events (AEs) and serious adverse events (SAEs) reflected the underlying disease.
The most commonly reported AEs include headache, fever (pyrexia), and upper respiratory tract infection.
No treatment-related AEs led to withdrawal from the study.
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Benzinga