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FDA extends Novartis' MS drug review

The US Food and Drug Administration has extended the review period for Novartis' investigational MS therapy, FTY720, by three months

Novartis has announced that the US Food and Drug Administration (FDA) has extended the review period for its investigational multiple sclerosis (MS) therapy, FTY720 (fingolimod), by three months.

The drug, which has been shown to have significant benefits for patients is potentially the first oral treatment for the relapsing form of the neurological disorder, and will now face the end of its review period in September, 2010.

FTY720 was initially set to have its review period end in June, 2010, after being granted priority review status by the FDA at the beginning of the year.

Drugs under priority review are typically ones that offer major advances in treatment or provide a treatment for which no adequate therapy exists. The time usually taken for the FDA to carry out a priority review of a drug is six months, compared to 10 months for a drug under standard review.

The extension comes after a request by the FDA for further analysis of data provided by Novartis - the largest ever set submitted to the agency to support approval of a new medicine in the treatment of MS.

Novartis responded to the request, though no further clinical trials were asked for.

Speaking about the extension, Dr Trevor Mundel, global head of development at Novartis, said: "The announcement of this revised timeline is in line with our expectations, and reflects the comprehensive clinical programme and resulting large amount of data to be reviewed in the new drug application (NDA).

"MS is a leading cause of neurological disability in young adults and we are very committed to bringing new therapies to patients with this disabling condition."

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee will continue with their scheduled meeting in June to discuss the benefit/risk profile of fingolimod – the active ingredient in FTY720.

25th May 2010

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