Novartis investigational treatment FTY720 (fingolimod) has received unanimous FDA approval for the treatment of patients with relapsing multiple scler

The advisory committee of FDA, that reviews and decides whether to approve a new treatment, has voted that FTY720 demonstrated substantial efficacy in treating relapsing remitting MS and that safety of the proposed 0.5mg dose justified approval.Novartis said that the committee has assessed data from the clinical trial program which provided evidence of superior efficacy of FTY720 over ointerferon beta-1a IM (Avonex), and to placebo, in reducing relapses and brain lesions (a measure of disease activity).Reportedly, the two-year placebo-controlled study showed FTY720 delayed disability progression. The advisory committee discussed monitoring parameters for the therapeutic use of FTY720 and also recommended post-marketing collection of additional safety data and evaluation of a lower dose..................& more