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Published on 14 January 2010

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Biogen asks for MS drug approval

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Tablets which may help MS patients’ walking have been sumbitted for marketing authorisation application by Swiss firm Biogen.

The application over tablet formulation of investigational drug fampridine (4-aminopyridine or 4-AP) went to the European Medicines Agency for Fampridine Prolonged Release (Fampridine-PR).

Biogen has also filed the tablets with Health Canada; in North America the therapy is called Fampridine-SR (sustained release).

It blocks potassium channels in demyelinated nerves, reducing current leakage from axons and restoring neuronal conduction.

“Fampridine-PR tablets may offer a novel approach to address walking impairment by improving the walking ability of MS patients,” said Alfred Sandrock, Biogen’s senior vice president of neurology research and development.

Results from two studies on patients with relapsing remitting, secondary progressive, progressive relapsing, and primary progressive MS were among submissions.

Fampridine-PR-treated patients showed a consistent improvement in walking speed (34.8% versus 8.3%) when compared with placebo (42.9% against 9.3%) across all types of MS included in the studies.

Acorda Therapeutics developed the formulation and will commercialise it in the US. Biogen will do so in the other markets.

The US Food and Drug Administration accepted a New Drug Application for Fampridine-SR and aims to complete its review by 22 January.

Copyright Press Association 2010

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