The US 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 tablet formulation can either be swallowed whole or dispersed in a teaspoon of filtered (non-chlorinated) water.
Over the past nine years, patients with spinal muscular atrophy have seen the number of FDA-approved treatment options for ...
This means patients who take the tablet can expect the same established efficacy and safety as the Evrysdi oral solution. The Evrysdi oral solution will remain available for those on other doses ...
The FDA on Wednesday approved the industry’s first-ever tablet treatment for spinal muscular atrophy— Roche ’s SMN2 splicing ...
The Muscular Dystrophy Association celebrates this new more accessible treatment option for people living with SMA. MDA - New ...
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 ...
This means patients who take the tablet can expect the same established efficacy and safety as the Evrysdi oral solution. The Evrysdi oral solution will remain available for those on other doses ...
Evrysdi tablet can be stored at room temperature and offers the same demonstrated efficacy and safety as the currently available oral solution – – New tablet formulation may provide greater ...
Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries Evrysdi tablet can be ...