Roche | MEDIA
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Roche’s Evrysdi tablet approved by European Commission as first and only for Spinal Muscular Atrophy (SMA)
The European Commission approved a new tablet formulation of Evrysdi (risdiplam) for spinal muscular atrophy (SMA). This room-temperature stable tablet offers simplified storage and administration compared to the oral solution. The tablet is bioequivalent to the existing solution, maintaining the same efficacy and safety profile. Over 18,000 individuals globally have been treated with Evrysdi, highlighting its established effectiveness. The new tablet is suitable for people aged two and older weighing at least 20kg. The oral solution will remain available. This approval reflects progress in SMA management, providing more convenient treatment options. Roche collaborated with the SMA Foundation and PTC Therapeutics on Evrysdi's development. Evrysdi increases SMN protein production, crucial for motor neuron health. The drug has received various accolades and approvals worldwide.