Evrysdi FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 27, 2021.
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 patients 2
months of age and older.
Development Timeline for Evrysdi
|Aug 7, 2020||Approval FDA Approves Evrysdi (risdiplam) for Treatment of Spinal Muscular Atrophy (SMA) in Adults and Children 2 Months and Older|
|Jun 12, 2020||Genentech Announces 2-Year Risdiplam Data From SUNFISH and New Data From JEWELFISH in Infants, Children and Adults With Spinal Muscular Atrophy (SMA)|
|Apr 27, 2020||Genentech’s Risdiplam Shows Significant Improvement in Survival and Motor Milestones in Infants With Type 1 Spinal Muscular Atrophy (SMA)|
|Apr 7, 2020||Genentech Provides Regulatory Update on Risdiplam for the Treatment of Spinal Muscular Atrophy (SMA)|
|Feb 6, 2020||Genentech’s Risdiplam Showed Significant Improvement in Motor Function in People Aged 2-25 With Type 2 or 3 Spinal Muscular Atrophy|
|Jan 22, 2020||Genentech’s Risdiplam Meets Primary Endpoint in Pivotal FIREFISH Trial in Infants With Type 1 Spinal Muscular Atrophy|
|Nov 24, 2019||FDA Grants Priority Review to Genentech’s Risdiplam for Spinal Muscular Atrophy|
|Nov 10, 2019||Genentech’s Risdiplam Meets Primary Endpoint In Pivotal SUNFISH Trial in People With Type 2 or 3 Spinal Muscular Atrophy|
|May 6, 2019||Genentech Presents Data from the Risdiplam Pivotal FIREFISH and SUNFISH Studies in Spinal Muscular Atrophy at the 2019 AAN Annual Meeting|
|Oct 3, 2018||Genentech Announces New Data for Risdiplam in Spinal Muscular Atrophy (SMA) at the World Muscle Society Congress|
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