Roche's aim to widen Evrysdi's label nabs speedy FDA review in young spinal muscular atrophy patients

Evrysdi, also known as risdiplam, snagged an FDA priority review for its use as a treatment in presymptomatic babies younger than two months old, Roche said Tuesday. The drug is already approved in the neuromuscular disease for adults, kids and babies two months and older. A green light in even younger infants would make Evrysdi the first medicine administered at home for presymptomatic babies with the debilitating disease, Roche said.