A to Z of MS Fingolimod

Also known as FTY720, Gilenia (brand name).

Fingolimod is an experimental disease modifying drug for multiple sclerosis that is still undergoing trials in both relapsing remitting and primary progressive MS.

Fingolimod research

A six month, phase II controlled clinical trial of fingolimod involving 255 people with relapsing remitting MS found inflammation measured on MRI scans was significantly reduced in treatment groups when compared to people on placebo. More people in the treatment group stayed relapse-free.

An 18 month extension of the original study, in which those previously taking a placebo started treatment, confirmed these results, with up to 70% remaining relapse-free after four years. These results were reported at the 2009 meeting of the Academy of American Neurologists (AAN).

A larger phase III trial was also reported at the AAN meeting. TRANSFORMS was a one year study involving 1,292 participants comparing two doses of fingolimod with interferon beta-1a (Avonex). 80 to 83% of the fingolimod groups remained relapse-free compared with 69% of those on interferon beta-1a.

The manufacturers, Novartis, submitted fingolimod for licensing in Europe at the end of 2009. The National Institute for Health and Clinical Excellence (NICE) has already suggested that it may include fingolimod in the next round of assessments as a treatment for both relapsing remitting and primary progressive MS.

In February 2010 the Food and Drug Administration (FDA) in the USA granted priority review to fingolimod. Priority review is granted to medicines for conditions with high unmet need or with inadequate available treatments and means that the review time will be reduced from ten months to six months. A Novartis press release announced that the FDA has extended its review period by three months to September 2010. The European review process is not affected. In June 2010, an advisory panel to the FDA recommended approval of fingolimod as a treatment for relapsing remitting multiple sclerosis.

The drug's European licensing submission is not as far advanced as it is in the USA and will not be affected by the FDA's decision.

How fingolimod works

Fingolimod works by binding to the surface of immune cells, trapping them in the lymph nodes and preventing them from attacking cells in the central nervous system.

How is fingolimod given?

Fingolimod is taken orally as tablets.

Side effects and contraindications

Although the trials so far have shown fingolimod to be well tolerated, the side effects that have occurred include upper respiratory tract infections, shortness of breath, diarrhoea and nausea.

Reference

Kappos L, et al.
Oral fingolimod (FTY720) for relapsing multiple sclerosis.
New England Journal of Medicine 2006;355(11):1124-1140.
abstract

Montalban X, et al.
Oral fingolimod (FTY720) shows sustained low rates of clinical and MRI disease activity in patients with relapsing multiple sclerosis: 4-year results from a phase II extension.
Poster presentation at the American Academy of Neurology Annual Meeting 2009. [P06.128].

Cohen J, et al.
Oral fingolimod vs intramuscular interferon in relapsing multiple sclerosis.
New England Journal of Medicine 2010. [epub ahead of print 20 January 2010]

Kappos L, et al.
Placebo-controlled study of oral fingolimod in relapsing multiple sclerosis.
New England Journal of Medicine 2010. [epub ahead of print 20 January 2010]

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