Fampridine

Fampyra was intended to improve the walking ability of people with MS, and has already been licensed in the US.

The ruling by the EMA’s Committee for Medicinal Products for Human Use  (CHMP) means that unless Biogen Idec successfully appeals or provides more evidence to show Fampyra’s safety and effectiveness, the drug will not be licensed throughout Europe. 

However, the company has said it is appealing the decision.

Fampyra is a tablet designed to act as a potassium channel blocker that works on damaged nerves and prevents charged potassium particles from leaving the nerve cells. This is expected to affect the stimulation of the muscles, in turn managing the symptoms of MS.

Late stage clinical trials showed that Fampyra improved walking speed by about 25 per cent in some people with MS.

However, the CHMP says it was not convinced that Fampyra’s small effect on the walking speed was a meaningful benefit for patients.

“The effect on speed could not be linked to meaningful improvements such as better coordination, balance or stamina or increased range of action,” it said.

Moreover, the committee said it was of the view that the medicine’s uncertain benefits did not outweigh its side effects.

These side effects include pain, dizziness, paraesthesia (unusual sensations like pins and needles) and problems with balance, as well as symptoms similar to those of MS, which could damage a person’s ability to walk.

The CHMP has called for adequate long-term data on Fampyra’s benefits.

However, those people included in trials and compassionate-use programmes will continue to take Fampyra as planned.

Dr Alfred Sandrock, Head of Neurology Research & Development at Biogen Idec has said the firm “will work closely with the CHMP during the appeal process to address the committee’s concerns”.

Biogen Idec reports that at the end of September 2010, approximately 6,300 prescribers had started around 31,000 MS patients on prolonged-release Fampridine tablet treatments in the US under the trade name Ampyra.

Further information

Fampridine Information Sheet (.pdf, 101KB)