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US FDA Extends Roche’s Risdiplam Decision Date

Move Triggered By Roche’s Submission Of Added Trial Data

 
• By Sten Stovall

The submission of more trial data from Roche has prompted the US FDA to extend by three months its decision on whether to approve risdiplam for spinal muscular atrophy.  

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FDA had previously set 24 May as date for deciding whether to approve Roche's drug • Source: Shutterstock

The US Food and Drug Administration has extended its priority review for Roche's candidate risdiplam in spinal muscular atrophy by three months from 24 May to 24 August, delaying its potential approval and giving more respite to its rivals.

The push back is owing to the submission of additional data by the Swiss company, including results from the pivotal SUNFISH Part 2 study, which Roche said could help provide access to the oral therapy

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