Evrysdi's EC label expanded to include new-born babies

The European Commission (EC) has approved the extension of the Evrysdi (risdiplam) European Union (EU) marketing authorization to include infants with a clinical diagnosis of spinal muscular atrophy (SMA) type one, type two or type three or with one to four SMN2 copies from birth to below two months.

Swiss pharma giant Roche’s (ROG: SIX) SMN2 splicing modifier was initially approved in Europe in March 2021 for the treatment of patients aged two months or older.

"The greatest chance to achieve the milestones of sitting, standing and walking, similar to healthy children"Evrysdi is the only non-invasive SMA therapy and is approved in 100 countries, with more than 11,000 patients treated globally.