DATA GRAPHICS | Regulation
February’s recommendations by EMA’s CHMP included a nod in favor of Roche’s Evrysdi risdiplam, setting the drug up to become the first oral spinal muscular atrophy therapy in Europe.
CHMP recommended, under its accelerated assessment pathway, approval of Evrysdi from Roche (SIX:ROG; OTCQX:RHHBY) to treat 5q SMA in patients ages 2 months of age and older. The indication covers patients who have a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or have 1-4 SMN2 copies...