Evrysdi is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies5

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing welwyn.uk_dsc@roche.com or calling +44 (0)1707 367554.

For full details, please refer to the Evrysdi® Summary of Product Characteristics (GB, NI)

Abbreviations

CNS, central nervous system; GB, Great Britain; mRNA, messenger ribonucleic acid; NI, Northern Ireland; SMA, spinal muscular atrophy; SMN2, survival motor neuron 2.

References

  1. Chiriboga CA, Bruno C, Duong T, et al. JEWELFISH: safety and pharmacodynamic data in non-naïve patients with spinal muscular atrophy receiving treatment with risdiplam. Presentation at: 2020 Virtual Cure SMA Conference; June 8-12, 2020; Virtual.
  2. Servais L, Baranello G, Masson R, et al. FIREFISH Part 2: efficacy and safety of risdiplam (RG7916) in infants with Type 1 spinal muscular atrophy (SMA). Presentation at: American Academy of Neurology Annual Meeting; April 25-May 1, 2020; Virtual.
  3. Day JW, Annoussamy M, Baranello G, et al. SUNFISH Part 1: 24-month safety and exploratory outcomes of risdiplam (RG7916) treatment in patients with Type 2 or 3 spinal muscular atrophy (SMA). Presentation at: 2020 Virtual Cure SMA Conference; June 8-12, 2020; Virtual.
  4. Mercuri E, Barisic N, Boespflug-Tanguy O, et al. SUNFISH Part 2: efficacy and safety of risdiplam (RG7916) in patients with Type 2 or non-ambulant Type 3 spinal muscular atrophy (SMA). Presentation at: American Academy of Neurology Annual Meeting; April 25-May 1, 2020; Virtual.
  5. Evrysdi® Summary of Product Characteristics (GB, NI)
  6. Baranello G, Servais L, Day JW, et al. FIREFISH Part 1: 1-year results on motor function in infants with Type 1 spinal muscular atrophy (SMA) receiving risdiplam (RG7916). Presentation at: 2019 Annual Cure SMA Conference; June 28-July 1, 2019; Anaheim, California.
  7. Mercuri E, Baranello G, Masson R, et al. SUNFISH Part 1: Safety, tolerability, PK/PD and exploratory efficacy data in patients with Type 2 or 3 spinal muscular atrophy (SMA) treated with risdiplam (RG7916). Presentation at: The 24th International Annual Congress of the World Muscle Society; October 1-5, 2019; Copenhagen, Denmark.

M-GB-00002774

Date of preparation: June 2021