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Evrysdi FDA Approval History

Last updated by Judith Stewart, BPharm on May 31, 2022.

FDA Approved: Yes (First approved August 7, 2020)
Brand name: Evrysdi
Generic name: risdiplam
Dosage form: for Oral Solution
Company: Genentech, Inc.
Treatment for: Spinal Muscular Atrophy

Evrysdi (risdiplam) is a survival of motor neuron 2 (SMN2) splicing modifier indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

Development timeline for Evrysdi

DateArticle
May 31, 2022Approval FDA Approves Label Extension for Evrysdi for Infants with Spinal Muscular Atrophy Under 2 Months Old
Aug  7, 2020Approval FDA Approves Evrysdi (risdiplam) for Treatment of Spinal Muscular Atrophy (SMA) in Adults and Children 2 Months and Older
Jun 12, 2020Genentech Announces 2-Year Risdiplam Data From SUNFISH and New Data From JEWELFISH in Infants, Children and Adults With Spinal Muscular Atrophy (SMA)
Apr 27, 2020Genentech’s Risdiplam Shows Significant Improvement in Survival and Motor Milestones in Infants With Type 1 Spinal Muscular Atrophy (SMA)
Apr  7, 2020Genentech Provides Regulatory Update on Risdiplam for the Treatment of Spinal Muscular Atrophy (SMA)
Feb  6, 2020Genentech’s Risdiplam Showed Significant Improvement in Motor Function in People Aged 2-25 With Type 2 or 3 Spinal Muscular Atrophy
Jan 22, 2020Genentech’s Risdiplam Meets Primary Endpoint in Pivotal FIREFISH Trial in Infants With Type 1 Spinal Muscular Atrophy
Nov 24, 2019FDA Grants Priority Review to Genentech’s Risdiplam for Spinal Muscular Atrophy
Nov 10, 2019Genentech’s Risdiplam Meets Primary Endpoint In Pivotal SUNFISH Trial in People With Type 2 or 3 Spinal Muscular Atrophy
May  6, 2019Genentech Presents Data from the Risdiplam Pivotal FIREFISH and SUNFISH Studies in Spinal Muscular Atrophy at the 2019 AAN Annual Meeting
Oct  3, 2018Genentech Announces New Data for Risdiplam in Spinal Muscular Atrophy (SMA) at the World Muscle Society Congress

See also

Evrysdi (risdiplam) Consumer information

Further information

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