FDA Approves Evrysdi Tablets: A Breakthrough in Convenient SMA Treatment
The FDA has approved Evrysdi (risdiplam) tablets for the treatment of spinal muscular atrophy (SMA)25.
Evrysdi is the first and only tablet formulation approved for SMA treatment, offering a non-invasive, disease-modifying option25.
The 5 mg Evrysdi tablet can be swallowed whole or dispersed in water, providing flexibility in administration25.
The tablet formulation is suitable for people 2 years of age or older who weigh more than 44 lbs (20 kgs)25.
Evrysdi tablets can be stored at room temperature, enhancing convenience for patients25.
The tablet form offers the same demonstrated efficacy and safety as the currently available oral solution25.
Evrysdi is approved in over 100 countries and has been used to treat thousands of patients to date25.
The approval was based on a bioequivalence study showing comparable exposure to risdiplam between the tablet and oral solution forms25.
Evrysdi's oral administration provides a convenience advantage over injectable treatments like Spinraza36.
The new tablet formulation may offer greater freedom and independence for people with SMA by simplifying dose administration25.
Sources:
2. https://www.biospace.com/press-releases/fda-approves-genentechs-evrysdi-tablet-as-first-and-only-tablet-for-spinal-muscular-atrophy-sma
3. https://www.fiercepharma.com/marketing/roche-s-low-price-evrysdi-will-take-meaningful-sma-share-from-biogen-s-spinraza-analyst
5. https://www.gene.com/media/press-releases/15052/2025-02-12/fda-approves-genentechs-evrysdi-tablet-a
6. https://www.e3s-conferences.org/articles/e3sconf/pdf/2021/47/e3sconficepe202103035.pdf