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Novartis MS drug performs well

Novartis MS therapy significantly reduces relapse rates according to phase III study

Novartis oral multiple sclerosis (MS) therapy FTY720 (fingolimod) significantly reduces relapses and disability progression by 30-32 per cent, according to results of a two-year phase III study.

Initial results from the FREEDOMS study show that FTY720 is superior to placebo in reducing both relapses and disability progression in patients with relapsing-remitting MS – one of the leading causes of neurological disability in young adults.

The FREEDOMS study met its primary and secondary endpoints for both the 0.5mg and 1.25mg doses, with no significant variation in efficacy between the doses. The results support previous data showing increased efficacy to interferon beta-1a in TRANSFORMS, the largest head-to-head phase III study against a standard of care treatment in MS.

Results from the placebo-controlled FREEDOMS study show that FTY720 reduced the relapse rate by 54 per cent for the 0.5g dose and 60 per cent for the 1.25mg dose compared with placebo.

"The positive results from the FREEDOMS study confirm the efficacy and safety of fingolimod, and provide important evidence of its effect on disability," said Professor Ludwig Kappos, chair of neurology and research group leader of the Department of Biomedicine at the University Hospital, Basel, and principal investigator of the FREEDOMS study. "As an oral therapy, it is clear that fingolimod potentially represents a significant advance in the treatment of MS."

FTY720 was generally well tolerated with a lower incidence of adverse events at 0.5mg than at 1.25mg. Novartis is planning regulatory submissions for FTY720, in the US and EU at the end of 2009, for the lower 0.5mg dose based on comprehensive phase III results establishing its positive benefit–risk profile.

FREEDOMS is the second of three phase III trials to report results in the largest development programme ever carried out in MS, involving more than 4,000 worldwide.

1st October 2009

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