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news.Novartis has reported the publication of results from two pivotal phase III clinical trials with oral FTY720 (fingolimod), of Transforms and Freedoms studies, in the New England Journal of Medicine. The outcome provided comprehensive evidence to support the efficacy and safety profile of FTY720 for multiple sclerosis (MS).
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Reportedly, the data from phase III programs conducted in MS, were included in the applications for regulatory approval submitted to the FDA and European Medicines Agency (EMEA), in December 2009. In both studies, two doses of FTY720 were examined (0.5mg and 1.25mg). Approval is sought for the lower 0.5mg dose as the results from the studies indicate that this dose has the most positive benefit-risk profile.
The one-year Transforms study involving 1,292 patients showed that oral FTY720 0.5mg reduced relapses by 52%, compared to interferon beta-1a (Avonex) given by intramuscular injection, while the reduction with FTY720 1.25mg was 38%.
Whereas, the two-year Freedoms study involving 1,272 patients, has showed that FTY720 reduced the relapse rate by 54% for the 0.5mg dose and 60% for the 1.25mg dose compared to placebo. Patients on FTY720 0.5mg also had a 30% lower risk of disability progression, three-month confirmed and a 37% lower risk of disability progression, six-month confirmed over two years compared to placebo. Similarly, the FTY720 1.25mg dose reduced the risk of three-month and six-month confirmed disability progression by 32% and 40%, respectively.
The company said that in both studies, treatment with FTY720 also resulted in reductions in brain lesion activity and reduced loss of brain volume as measured by magnetic resonance imaging (MRI).
The company claims that FTY720 has the potential to be the first approved therapy in a new class of drugs called sphingosine 1-phosphate (S1P) receptor modulators. These medicines reduce inflammation and may also have a direct beneficial effect on cells in the central nervous system (CNS).
In the studies, FTY720 acts selectively by retaining certain lymphocytes in the lymph nodes, reducing the number of lymphocytes that reach the brain where they can cause inflammatory destruction. This lymphocyte retention is reversible, allowing circulating lymphocytes to regain normal levels if treatment is stopped. In both Transforms and Freedoms, adherence to therapy was best for the FTY720 0.5mg and control groups compared to the 1.25mg group.
Reportedly, the completed MS FTY720 studies and their extensions include more than 2,300 patients with approximately 4,000 patient-years of exposure, including some patients now in their sixth year of treatment. Safety is also being monitored in approximately 1,000 additional patients in ongoing MS studies.
Trevor Mundel, global head of development at Novartis, said: “These data demonstrate that oral FTY720 has the potential to offer an important new treatment option for patients with MS. We have a long-term commitment to the MS community, and trust that FTY720, once approved, will prove to be a valuable treatment option for many people who live with this disease.”