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Roche's Evrysdi Becomes First SMA Pill

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Roche's Evrysdi has made a significant breakthrough as the first oral medication approved for spinal muscular atrophy (SMA). This innovative treatment stands out because it's noninvasive, which means it doesn't require procedures like injections or surgeries to be administered. This is a big deal for patients because it simplifies the treatment process and can be taken at home.

The approval of Evrysdi is a milestone in SMA care, offering a new level of convenience and accessibility for patients. It's a game-changer for those affected by SMA, as it provides a disease-modifying treatment that can be easily integrated into daily life. This development is expected to have a positive impact on patient outcomes and quality of life. For more details on this groundbreaking treatment, check out the Biospace Blog (2025).

Community News

Cure SMACure SMAFeb 12, 2025

Today, Genentech/Roche announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for an Evrysdi® (risdiplam) tablet for people living with SMA.

The approval of the Evrysdi tablet was based on the results of a bioequivalence study, which demonstrated that the 5 mg tablet, whether swallowed whole or dispersed in non-chlorinated drinking water (e.g., filtered water), and original oral solution provide comparable exposure to risdiplam.

The new tablet, expected to be available in the coming weeks, is suitable for people two years of age or older who weigh more than 20 kgs (44 lbs).

https://www.curesma.org/fda-approves-roches-evrysdi-tablet-as-first-and-only-tablet-for-spinal-muscular-atrophy-sma/

Cure SMA Post
Spinal Muscular Atrophy UKSpinal Muscular Atrophy UKFeb 13, 2025

🚨 FDA approves Roche’s Evrysdi® (risdiplam) as the first and only tablet formulation for SMA – same demonstrated efficacy and safety, more convenience. UK access updates coming soon! 📣

Read more 👉 smauk.org.uk/treatments-research/risdiplam/

Spinal Muscular Atrophy UK Post
SpinalMuscularAtrophy.netSpinalMuscularAtrophy.netFeb 18, 2025

Community members talk about overcoming obstacles with SMA:

SpinalMuscularAtrophy.net Post

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Evrysdi® tablet approval webinar Cure SMA • Elk Grove Village, IL    Online
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