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Published on 25 May 2010

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FDA extends its review period

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Novartis announced today that the US Food and Drug Administration (FDA) has extended by three months, to September 2010, its review period for the regulatory approval of FTY720 (fingolimod).

FTY720 once-daily 0.5 mg has the potential to be the first oral therapy for relapsing multiple sclerosis (MS).

A meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee remains scheduled for June 10, 2010, to discuss the benefit/risk profile of this new active ingredient (New Molecular Entity).

The FDA granted priority review status for FTY720 in February 2010, reducing the standard 10-month review period to six months, which was set to end on June 21, 2010.  The extension was based on the FDA’s request for further analysis of available data, which Novartis responded to and which triggered the three-month extension. The agency did not ask for additional clinical trials. Priority reviews are granted by the FDA for investigational medicines that could offer significant advances beyond current treatments or where no adequate therapy exists.

“The announcement of this revised timeline is in line with our expectations, and reflects the comprehensive clinical program and resulting large amount of data to be reviewed in the NDA,” said Trevor Mundel, MD, Global Head of Development at Novartis Pharma AG. “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.”

Data from the FTY720 MS clinical trial program, the largest ever submitted to the FDA to support approval of a new medicine in this therapeutic area, have demonstrated the significant benefits of FTY720 in reducing relapses in people with MS.

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