Primary Endpoint Qualification of SV95C by European Medicines Agency

SYSNAV Healthcare Announces EMA Primary Endpoint Qualification of Stride Velocity 95th Centile (SV95C) for Duchenne Muscular Dystrophy.


EMA opinion marks the first qualification of a digital outcome measure for use as a primary endpoint in pivotal drug trials.


SV95C is an objective, real-world digital ambulation measure of top performance, informing more confident treatment decision-making and streamlining drug development, with potential to shorten trial durations or decrease enrollment requirement.


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