Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats spinal muscular atrophy (SMA). Sold as Evrysdi. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 2 applications for Risdiplam (sold as Evrysdi), first approved Aug 7, 2020, with 4 new uses approved and 0 published complete response letters.
First approved: Aug 7, 2020
Applications: 2
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $184M
Orphan exclusivity until: May 27, 2029
First approved in the EU: Mar 26, 2021
First approved in Japan: Jun 23, 2021
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
Treatment of spinal muscular atrophyGenentech, Inc., a Member of the Roche Group · designated Jan 4, 2017 · approved Aug 7, 2020 · exclusive to Aug 7, 2027
Treatment of spinal muscular atrophyGenentech, Inc., a Member of the Roche Group · designated Jan 4, 2017 · approved May 27, 2022 · exclusive to May 27, 2029
Approvals in the EU (EMA)
First approved in the EU 8 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals
First approved in Japan 11 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
EvrysdiA drug with a new indication and a new additional pediatric dosage (under 2 months of age) for the treatment of spinal muscular atrophy. · Chugai Pharmaceutical Co., Ltd. · Sep 24, 2024
Evrysdi, new ingredientA drug with a new active ingredient indicated for the treatment of spinal muscular atrophy. · Chugai Pharmaceutical Co., Ltd. · Jun 23, 2021
Clinical Trials
11 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
