The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for people living with spinal muscular atrophy (SMA).
The new tablet is expected to be available in the coming weeks and is suitable for people aged 2 years and older who weigh more than 44 lbs.
The approval of the Evrysdi tablet was based on the results of a bioequivalence study, which demonstrated that the 5-mg tablet, either swallowed whole or dispersed in filtered water, provided comparable exposure to the original oral solution of Evrysdi. The Evrysdi oral solution will remain available for those on other doses of Evrysdi and for those who may prefer the oral solution.
“We cannot underestimate the value that comes with simplifying treatment administration and disease management for people who are living with SMA or those caring for them,” Kenneth Hobby, president of Cure SMA, said in a statement. “This new room temperature stable formulation option offers an additional choice that may more conveniently fit into daily living activities such as working, traveling, and education.”
Approval of Evrysdi was granted to Genentech.
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FDA approves tablet form of Evrysdi for spinal muscular atrophy (2025, February 18)
retrieved 18 February 2025
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The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for people living with spinal muscular atrophy (SMA). The new tablet is expected to be available in the coming weeks and is suitable for people aged 2 years and older who weigh more than 44 lbs. The approval of the Evrysdi tablet was based on the results of a bioequivalence study, which demonstrated that the 5-mg tablet, either swallowed whole or dispersed in filtered water, provided comparable exposure to the original oral solution of Evrysdi. The Evrysdi oral solution will remain available for those on other doses of Evrysdi and for those who may prefer the oral solution. “We cannot underestimate the value that comes with simplifying treatment administration and disease management for people who are living with SMA or those caring for them,” Kenneth Hobby, president of Cure SMA, said in a statement. “This new room temperature stable formulation option offers an additional choice that may more conveniently fit into daily living activities such as working, traveling, and education.” Approval of Evrysdi was granted to Genentech. © 2025 HealthDay. All rights reserved. Citation: This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no
FDA approves tablet form of Evrysdi for spinal muscular atrophy (2025, February 18)
retrieved 18 February 2025
from https://medicalxpress.com/news/2025-02-fda-tablet-evrysdi-spinal-muscular.html
part may be reproduced without the written permission. The content is provided for information purposes only.
