Biogen submits Fampridine PR to European regulators
pharmafile | January 14, 2010 | News story | Sales and Marketing | Biogen, Fampridine, MS
Biogen Idec is seeking European approval for a drug which helps multiple sclerosis sufferers to walk better.
A marketing authorisation application has been submitted to the European Medicines Agency for Fampridine Prolonged Release (Fampridine-PR), the tablet formulation of investigational drug fampridine (4-aminopyridine or 4-AP).
The Swiss company has also filed the novel oral therapy with Health Canada; in North America it is known as Fampridine-SR (sustained release).
“Walking impairment has a significant impact on the lives of many people living with MS,” said Alfred Sandrock, Biogen’s senior vice president of neurology research and development.
“Fampridine-PR tablets may offer a novel approach to address this debilitating aspect of the disease by improving the walking ability of MS patients. We look forward to working with regulators to make this therapy available to people with MS in Europe and Canada.”
MS is a chronic disease affecting millions of people – more women than men – and typically manifesting itself in patients under 50 years of age.
It is characterised by interference with messages from the brain to the body due to damage to myelin, the protection around nerve fibres in the central nervous system.
The drug acts by blocking the potassium channels in demyelinated nerves, reducing the leakage of current from the axons and restoring neuronal conduction.
Biogen’s submissions include results from two phase III studies on patients with relapsing remitting, secondary progressive, progressive relapsing, and primary progressive MS.
Fampridine-PR-treated patients had a consistent improvement in walking speed (34.8% versus 8.3%) when compared to placebo (42.9% against 9.3%) across all types of MS included in the studies.
The tablet formulation was developed by Acorda Therapeutics, which will commercialise it in the US, with Biogen doing the same in all other markets.
The US Food and Drug Administration has accepted a New Drug Application for Fampridine-SR and aims to complete its review by 22 January.
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