Roche announces that its Evrysdi tablet has been approved by the European Commission as a treatment for spinal muscular atrophy (SMA).

Evrysdi is the only non-invasive disease-modifying treatment available for people with spinal muscular atrophy (SMA).

The approval is based on data from a bioequivalence study ( NCT04718181 ) evaluating the 5 mg tablet formulation of Evrysdi, which can be swallowed whole or disolved in water.

Evrysdi is designed to treat spinal muscular atrophy (SMA) by increasing and maintaining SMN protein production throughout the central nervous system (CNS) and peripheral tissues.

The new Evrysdi tablet, with its flexibility of administration, represents a step forward in providing more versatile care for people with spinal muscular atrophy,  Roche said.

With over 18,000 people treated to date, the proven efficacy, safety, and convenience of Evrysdi have significantly improved the course of the disease for people with spinal muscular atrophy.


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