
Roche’s Evrysdi tablet approved in EU for spinal muscular atrophy
Ella Day | June 5, 2025 | News story | Research and Development | European Commission, Evrysdi, Neurology, Roche, european union, neuromuscular condition, spinal muscular atrophy (SMA)
Roche has received approval from the European Commission for a new tablet formulation of Evrysdi (risdiplam), marking the first and only tablet available for the treatment of spinal muscular atrophy (SMA), a rare, genetic neuromuscular condition. The label extension allows the 5mg tablet to be used across the EU, offering an alternative to the existing oral solution.
The tablet can be taken with or without food, does not require refrigeration and may be swallowed whole or dispersed in water. It is suitable for individuals aged two and over who weigh at least 20kg and can swallow without a feeding tube.
Evrysdi is currently the only non-invasive, disease-modifying treatment for SMA and is administered at home. It has been used to treat more than 18,000 people globally. The new formulation is intended to improve convenience and independence for those living with SMA, as well as their caregivers.
“The new Evrysdi tablet with its flexible administration represents progress toward more versatile SMA disease management,” said Levi Garraway, chief medical officer and head of global product development at Roche.
The approval follows a bioequivalence study showing that the tablet and oral solution obtain the same efficacy and safety profile. Both formulations aim to increase production of SMN protein, which is deficient in people with SMA.
Evrysdi is part of a collaboration between Roche, the SMA Foundation and PTC Therapeutics. It is currently approved in over 100 countries.
Ella Day
5/6/25
Related Content

European Commission approves HIV prevention injection
The European Commission (EC) has granted marketing authorisation for Gilead Science’s Yeytuo (lenacapavir), the first …

Roche receives CE Mark for blood test to help rule out Alzheimer’s
Roche has been granted CE Mark approval for its Elecsys pTau181 test, the first in …

Sanofi’s Sarclisa gains EU approval for multiple myeloma treatment
Sanofi has received approval from the European Commission for the use of Sarclisa (isatuximab) in …






