EMA OKs First Digital Outcome As Primary Endpoint In Duchenne Studies

Digital Endpoint Can Be Used As An Alternative To The 6 Minute Walking Test

15 Aug 2023

A digital outcome for measuring the top walking speed of patients at home that can be captured using wearable devices has been approved by the European Medicines Agency as an alternative primary endpoint in ambulatory Duchenne Muscular Dystrophy studies.

Medicine doctor hands with digital medical interface icons on blur background, Medical technology and healthcare smart watch concept. — A Real-World Digital Endpoint Can More Accurately Reflect The Patient’s Daily Functioning • Source: Shutterstock

The European Medicines Agency has endorsed the use of a digital outcome measure, Stride Velocity 95th Centile (SV95C), as a primary endpoint in superiority studies for ambulant Duchenne Muscular Dystrophy (DMD) patients aged four years and above.

SV95C is a clinical outcome measure that represents the fastest 5% of strides taken by a patient in normal daily...