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

  • Roche Holdings AG 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.
  • Price Action: RHHBY shares are up 0.51% at $35.25 on the last check Monday.
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