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FDA grants priority review to MS drug

Novartis has announced that its MS treatment, Gilenia (fingolimod) has been granted priority review status by the US FDA

Novartis has announced that its multiple sclerosis (MS) treatment, Gilenia (fingolimod) has been granted priority review status by the US Food and Drug Administration (FDA). This follows the acceptance of Novartis' regulatory submission made to the FDA in December 2009.

Gilenia is a once-daily oral therapy. Should the drug receive approval from the FDA, it has the potential to become the first approved oral therapy for the treatment of MS.

A priority review is granted by the FDA for investigational medicines that could offer significant advances beyond current treatments or where no adequate therapy exists. As a result of this designation, the standard 10-month FDA review period will be reduced to six months.

It is expected that the FDA will require an Advisory Committee meeting as Gilenia involves a new active ingredient. This could result in the FDA extending its review at the end of the six-month period in June 2010.

"We welcome the decision granting priority review to Gilenia, which underscores the potential benefits of this medicine to patients," said Dr Trevor Mundel, global head of development at Novartis Pharma AG.

"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," he continued.

Data from one of the largest-ever phase III clinical trial programmes conducted in MS patients were submitted to support the US and European regulatory submissions, including results of the TRANSFORMS and FREEDOMS studies that were recently published in The New England Journal of Medicine.

Data drawn from a combination of both studies showed that Gilenia reduced relapses, disability progression and brain lesions in patients with the relapsing-remitting form of MS, which is estimated to affect around 85 per cent of MS patients.

22nd February 2010

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