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A new multiple sclerosis (MS) drug has been granted priority review status by the Food and Drug Administration (FDA).
The fingolimod oral pill application was submitted to the US regulator for review at the end of last year by healthcare products company Novartis Pharmaceuticals AG.
The priority review, which is authorised in cases when there is inadequate available treatments or for medicines with high unmet needs, should take six months to complete rather than the usual 10 months.
It is hoped the priority status should speed up the time it takes for the drug to be available to patients in the US. It has been hailed as having the potential to offer “real advances” in the treatment of people with MS.
Trevor Mundel, global head of development at Novartis, said: “We welcome the decision granting priority review to fingolimod, which underscores the potential benefits of this medicine to patients.
“MS is a leading cause of neurological disability in young adults, particularly in women, and this medicine has the potential to offer real advances in the care of people with MS.”
Copyright Press Association 2010
Novartis
