Evrysdi (risdiplam), developed by Genentech, Inc., a member of the Roche Holding AG (RHHBY), was approved by the FDA on August 7, 2020, for the treatment of spinal muscular atrophy (SMA) in adults and children 2 months of age and older.This approval came ahead of its PDUFA date which was slated for August 24.Spinal muscular atrophy, which usually affects babies and children, is a progressive, neurodegenerative disease often inherited through genes.Evrysdi is a survival of motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency.Evrysdi increases the production of the survival motor neuron (SMN) protein. The list price of the drug varies according to the weight of the infant- a maximum of $340,000 per year for children of about 44 pounds and about $100,000 annually for children below 2 years, whose average weight is found to be 15 pounds.Analysts expect peak sales of about $2 billion for Evrysdi.Rival drug, Biogen's Spinraza, approved in Dec. 2016 had annual sales of $2.097 billion in 2019. Novartis' Zolgensma was approved for the treatment of SMA in May 2019.Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018. Genetech is planning to submit a Marketing Authorization Application (MAA) to the EMA soon.