Roche announced that the European Commission has approved a label extension for Evrysdi (risdiplam), allowing a new 5mg tablet formulation to be used in treating spinal muscular atrophy (SMA). The room-temperature stable tablet can be swallowed whole or dispersed in water, offering patients and caregivers more flexibility in daily disease management. Suitable for individuals aged two years or older who weigh at least 20kg, this tablet formulation can be taken with or without food and does not require refrigeration. It provides an alternative to the oral solution, which remains available for other dosing needs. The approval is based on data from a bioequivalence study confirming that the tablet form offers the same safety and efficacy profile as the original oral solution.
Levi Garraway, M.D., Ph.D., Chief Medical Officer at Roche, stated, “The new Evrysdi tablet with its flexible administration represents progress toward more versatile SMA disease management.” Nicole Gusset, CEO of SMA Europe, added, “This is a disease requiring daily management, and it is paramount that people living with SMA, and those who care for them, are given options to optimise treatment administration.” Roche developed Evrysdi in collaboration with the SMA Foundation and PTC Therapeutics. With more than 18,000 people treated to date and approvals in over 100 countries, Evrysdi remains the only non-invasive SMA treatment administered at home.
