6-minute walk test (6MWT)

The 6-minute walk test (6MWT) is an endpoint used to assess functional exercise capacity. It measures the distance an individual can walk on a hard, flat surface over a period of six minutes. In the context of regulatory reviews, it serves as a quantitative measure of physical endurance and is often used as a primary or secondary endpoint in clinical trials evaluating treatments for various conditions affecting mobility.

Reviews in this library demonstrate its application across different drug evaluations. For instance, in the Pfizer Inc. — Vyndaqel EMA EPAR variation assessment report, the LS mean change from Baseline in 6MWT at Month 30 (placebo) was recorded as -130.55 metres. The Alnylam B V — Amvuttra EMA EPAR variation assessment report noted a 6-minute walk test (6-MWT) change from baseline (LS mean difference) of 26.46 meters. Furthermore, the Biogen Inc. — Spinraza FDA Review reported a 6MWT mean (SD) increase of 34.8 (37.4) meters.