Roche and PTC’s Evrysdi (risdiplam) Receive the EC’s Approval as First and Only at Home Treatment For Spinal Muscular Atrophy

March 30, 2021 Auto Bot regulatory 0

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

Click here to­ read full press release/ article | Ref: Roche | Image: Roche

The post Roche and PTC’s Evrysdi (risdiplam) Receive the EC’s Approval as First and Only at Home Treatment For Spinal Muscular Atrophy first appeared on PharmaShots.