Accelerated Approval: Potential Sources Of Confirmatory Evidence Weighed At Tofersen Review

 
• By Sue Sutter

‘Clear signal’ in the ATLAS study of presymptomatic, SOD1 mutation carriers could provide evidence needed to confirm tofersen’s benefit in symptomatic ALS patients, FDA’s Teresa Buracchio says, adding that getting confirmatory evidence from the VALOR open-label extension 'could be a little more tricky.'

Eggs in nest
Biogen has proposed several sources of confirmatory and supportive evidence for tofersen's clinical benefit. • Source: Shutterstock

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