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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You can also visit the links below to read more about SV95C qualification !
- Pink Sheet: EMA OKs First Digital Outcome As Primary Endpoint In Duchenne Studies
- Pharmaphorum: EMA Backs SV95C as Digital Primary Endpoint for DMD Trials
- PMLiVE: EMA Endorses Digital Measure as Primary Endpoint in Duchenne Muscular Dystrophy Trials
- European Hospital & Healthcare Management: EMA Approves Stride Velocity 95th Centile (SV95C) as Primary Endpoint for Ambulant Duchenne Muscular Dystrophy Patients: A Milestone for Sysnav Healthcare
- Express Healthcare Management: EMA Qualifies SV95C as Primary Endpoint in Drug Trials for Duchenne Muscular Dystrophy Patients
- Fior Reports: Sysnav Healthcare Announces EMA Qualification for the Primary Endpoint of Walking Speed 95th Centile (SV95C) for Duchenne Muscular Dystrophy
- Pharmatales: SV95C is Approved by EMA as the Digital Primary Endpoint for DMD Trials