Shots:

• The approval is based on two studies i.e. FIREFISH and SUNFISH. The FIREFISH study involves assessing Evrysdi in infants aged 2-7mos. with symptomatic Type 1 SMA- and the SUNFISH study assesses Evrysdi in children & young adults with Type 2 or 3 SMA
• Evrysdi demonstrated a favourable efficacy & safety profile- with the safety profile established across both trials. The EU approval is applicable to all 27 European Union member states- as well as Iceland- Norway- and Liechtenstein
• The approval follows the positive CHMP’s recommendation- received in Feb’2021. Evrysdi has currently been approved in 38 countries and submitted in a further 33 countries

  Ref: Roche | Image: Roche