SMA Newsroom

ResearchJun 27, 2022

Poster on MANATEE: Roche and Genentech clinical study of GYM329 (RO7204239) in combination with risdiplam treatment in children with SMA

MANATEE is a global, Phase 2/3 study that will assess GYM329 in combination with risdiplam in ambulant (able to walk independently) children with SMA aged 2-10 years. Children who have been previously treated with either risdiplam, nusinersen or onasemnogene abeparvovec are eligible, as well as those who have not received treatment before. Other eligibility criteria exist. 

For more information, please see below to consult the poster.

ResearchTreatmentsClinical trialsMay 31, 2022

Roche Community Update: FDA (U.S. Food and Drug Administration) approves a label expansion for risdiplam

Today, the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular atrophy (SMA). This means that risdiplam is now approved in the US to treat SMA in children and adults of all ages.