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Results of the TRANSFORMS[1] and FREEDOMS[2] studies, the two pivotal Phase III clinical trials with oral FTY720 (fingolimod), have been published in The New England Journal of Medicine, providing comprehensive evidence to support the efficacy and safety profile of this first-in-class therapy for multiple sclerosis (MS).
The data, from one of the largest Phase III programs conducted in MS, were included in the applications for regulatory approval submitted to the US Food and Drug Administration (FDA) and European Medicines Agency (EMEA) in December 2009. In both studies, two doses of FTY720 were examined (0.5 mg and 1.25 mg). Approval is sought for the lower 0.5 mg dose as the results from the studies indicate that this dose has the most positive benefit-risk profile.
“Innovative science leading to new medicines for MS patients is greatly needed,” said John Richert, MD, Executive Vice President for Research and Clinical Programs at the US National Multiple Sclerosis Society. “The positive results published in The New England Journal of Medicine showing benefit of fingolimod on the clinical and MRI outcomes assessed is very encouraging for MS patients, their families and their physicians.”
The one-year TRANSFORMS study involving 1,292 patients showed that oral FTY720 0.5 mg reduced relapses by 52% compared to interferon beta-1a (Avonex((R)))? given by intramuscular injection, while the reduction with FTY720 1.25 mg was 38% (both p<0.001). The two-year FREEDOMS study, involving 1,272 patients, showed that FTY720 reduced the relapse rate by 54% for the 0.5 mg dose and 60% for the 1.25 mg dose compared to placebo (both p<0.001).
Patients on FTY720 0.5 mg also had a 30% lower risk of disability progression, three-month confirmed (p=0.02) and a 37% lower risk of disability progression, six-month confirmed (p=0.01) over two years compared to placebo. Similarly, the FTY720 1.25 mg dose reduced the risk of three-month and six-month confirmed disability progression by 32% (p=0.02) and 40% (p=0.006) respectively.
