FAMPYRA (fampridine), voltage-dependent potassium channel blocker
Reason for request
Low clinical benefit in the management of walking disorders in multiple sclerosis patients
FAMPYRA has been granted a marketing authorisation for the improvement in walking ability of patients suffering from multiple sclerosis (MS) and presenting with a walking handicap (EDSS 4-7).
The data derived from a new phase III study have confirmed its modest efficacy versus placebo on walking ability, along with the existence of a small fraction of responders that cannot be identified beforehand.
Its tolerance profile is marked by high, though relatively infrequent risks of convulsions, severe hypersensitivity and urinary tract infection.
It failed to improve the quality of life of the patients in the clinical studies.