Fampyra
Neurology· 942 cited findings· 2 source documents
Company: Merz Pharma
What the regulatory reviews say
Fampyra is indicated for the improvement of walking in adult patients with multiple sclerosis (MS) with walking disability. In the MOBILE study (218MS205), a 24-week treatment duration study, the MSWS-12 responder rate for Fampyra was 43.2%. The risk difference for MSWS-12 responder rate was 10.4%. The MSWS-12 LS mean change was -6.73 points, with a difference of -4.14 compared to the comparator arm. Patient Global Impression of Change (PGIC) improvement at Week 2 was 31% and 38%, and at Week 24, it was 22% and 28%. The relative risk of improvement in walking ability was 1.38.
Discontinuation due to adverse events was 7% for both fampridine and placebo. Discontinuation due to lack of efficacy for fampridine-PR was <1%, compared to 3% for placebo. In another study, 21 patients discontinued due to adverse events with Fampridine 10 mg BID, while 23 discontinued with placebo. Discontinuation due to lack of efficacy was 2 for Fampridine 10 mg BID and 10 for placebo.
Fampyra received a conditional marketing authorisation in 2011. The application was submitted on 23 December 2009. Following a negative CHMP opinion on 20 January 2011, a positive re-examination opinion was issued on 19 May 2011.
Key figures — cited to the source page
| MSWS-12 responder rate | 43.2% | Merz — Fampyra EMA EPAR variation assessment report (EMEA/H/, p.5 |
| MSWS-12 responder rate risk difference | 10.4% | Merz — Fampyra EMA EPAR variation assessment report (EMEA/H/, p.5 |
| MSWS-12 LS mean change difference | -4.14 | Merz — Fampyra EMA EPAR variation assessment report (EMEA/H/, p.5 |
| Relative risk of improvement in walking ability | 1.38 | Merz — Fampyra EMA EPAR variation assessment report (EMEA/H/, p.6 |
| Discontinuation due to adverse events (fampridine) | 7% | Merz — Fampyra EMA EPAR variation assessment report (EMEA/H/, p.11 |
| Discontinuation due to adverse events (placebo) | 7% | Merz — Fampyra EMA EPAR variation assessment report (EMEA/H/, p.11 |
| Conditional marketing authorisation granted | 2011 | Merz — Fampyra EMA EPAR variation assessment report (EMEA/H/, p.4 |
| CHMP positive re-examination opinion date | 19 May 2011 | Merz — Fampyra EMA EPAR public assessment report (EMEA/H/C/0, p.5 |
Source documents
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.