Safety information in infants with Type 1 SMA from the FIREFISH trial 1,8
Safety information in children and adults with Type 2 or Type 3 SMA from Part 2 of the SUNFISH trial 1
- The most common adverse
reactions reported in ≥10% of patients receiving Evrysdi and at an
incidence greater than placebo were fever, diarrhea, and rash
- No patients discontinued Evrysdi as a result of
treatment-related adverse reactions during the 12 months on
treatment in the FIREFISH and SUNFISH trials
Initial safety findings from JEWELFISH have been consistent with the safety in FIREFISH and SUNFISH 7
The trial includes participants who were previously treated with investigational or approved SMA therapies. 6
*Includes all URTI-basketed events. Most common
events (10%) in the basket include URTI, nasopharyngitis,
respiratory tract infection, and rhinitis.
†Includes rash, erythema, rash maculopapular, dermatitis, rash papular, dermatitis allergic, and folliculitis.
‡Includes pyrexia and hyperpyrexia.
§ Includes rash, erythema, rash maculopapular, rash erythematous, rash papular, dermatitis allergic, and folliculitis.
||Includes urinary tract infection and cystitis.