Merz — Fampyra EMA EPAR variation assessment report (EMEA/H/C/002097, 2011)

Merz · 2011 · EMA EPAR variation assessment report

Report summary

This EMA report details the variation assessment for Fampyra (fampridine), converting its conditional marketing authorization to full based on the ENHANCE study (218MS305). This long-term, randomized, placebo-controlled trial in 636 MS patients met its primary endpoint, demonstrating statistically significant improvements in MSWS-12 scores and TUG speed. The safety profile remained consistent with previous findings, showing no new concerns, though fampridine-PR had slightly higher incidences of certain adverse events like UTIs and insomnia. The FOLLOW pregnancy registry provided limited but positive data. The report also addresses routine risk minimization measures for overdose, hypersensitivity, UTIs, drug interactions, and precautions for specific patient populations, while removing long-term efficacy as a missing information safety concern.

Key findings — cited to the page

MSWS-12 responder rate risk difference	10.4%	ENHANCE (218MS305) · p.5
MSWS-12 LS mean change	-6.73 point	ENHANCE (218MS305) · p.5
MSWS-12 LS mean change	-2.59 point	ENHANCE (218MS305) · p.5
MSWS-12 LS mean change difference	-4.14	ENHANCE (218MS305) · p.5
PGIC improvement at Week 2	31%	ENHANCE (218MS305) · p.5
PGIC improvement at Week 2	38%	ENHANCE (218MS305) · p.5
PGIC improvement at Week 24	22%	ENHANCE (218MS305) · p.5
PGIC improvement at Week 24	28%	ENHANCE (218MS305) · p.5
Relative risk of improvement in walking ability	1.38	ENHANCE (218MS305) · p.6
MOBILE study (218MS205) enrolment	132 subjects	MOBILE (218MS205) · p.8
MOBILE study (218MS205) treatment duration	24 weeks	MOBILE (218MS205) · p.8
MSWS-12 responder rate	43.2%	ENHANCE (218MS305) · p.5

Source: Merz ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →