FDA approves sNDA for Novartis’ oral MS drug Gilenya

Gilenya, or Fingolimod, is the first approved oral disease modifying drug for MS.

FDA approves sNDA for Novartis’ oral MS drug Gilenya

Postby MSUK » Wed Aug 03, 2011 5:24 am


Novartis Pharmaceuticals Corporation announced that the U.S. Food and Drug Administration’s approval of a supplemental New Drug Application (sNDA) for Gilenya™ (fingolimod) that includes T1 Gd-enhancing magnetic resonance imaging (MRI) data. Gilenya is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS) in adults. It can decrease the number of MS flare-ups (relapses). It does not cure MS but can help slow down the physical problems that MS causes.

T1 Gd-enhancing lesions are areas of active inflammation in the central nervous system (CNS) and represent an important marker of disease activity in people with MS.

“Neurologists commonly use gadolinium contrast MRI activity to assess for active inflammation in people living with MS,” said Barry Singer, MD, Director of The MS Center for Innovations in Care at Missouri Baptist Medical Center. “These data show that treatment with Gilenya helped to significantly reduce contrast MRI activity in people with relapsing-remitting MS.” ... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1309
MS-UK - http://www.ms-uk.org/
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