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A to Z of MS Fingolimod (Gilenya)

Product name

Gilenya

During development the drug was known as FTY720

Fingolimod is a disease modifying drug for relapsing remitting multiple sclerosis. It is also undergoing trials as a potential treatment for primary progressive MS.

Fingolimod is licensed for people with rapidly evolving severe relapsing remitting MS (two or more relapses a year), and for people who continue to have relapses despite treatment with one of the beta interferon drugs or glatiramer acetate (Copaxone). Fingolimod can also be used by people switching from natalizumab (Tysabri) who are at high risk of developing PML.


Fingolimod research

Relapsing remitting MS
Two main studies have provided the evidence to support licensing of fingolimod for relapsing remitting MS:

  • FREEDOMS was a double-blind, placebo-controlled study involving 1,272 people with relapsing remitting MS in 22 countries. Participants received one of two doses of fingolimod or placebo over two years.

    The relapse rate for people in the placebo group was 0.40, compared to 0.18 for a 0.5mg fingolimod dose (a reduction of 54%) and 0.16 with a 1.25 mg dose (a reduction of 60%). The reduction of progression of disability was 30% and 32% respectively compared to placebo.
  • TRANSFORMS was a one year phase III study. It compared two doses of fingolimod (0.5mg and 1.25mg) against interferon beta-1a (Avonex) in 1,292 people with relapsing remitting MS.

    Relapse rates at one year were 0.33 for interferon beta-1a, 0.16 on the lower dose of fingolimod (a reduction of 52% compared to interferon beta-1a) and 0.2 on the higher dose (a 38% reduction). 80-83% of the fingolimod groups remained relapse-free over the year compared with 69% of those on interferon beta-1a.

Primary progressive MS
Laboratory investigations provided evidence that, in addition to its effect on the immune system, fingolimod may have neuroprotective and remyelinating properties in the brain and spinal cord.

  • INFORMS is a phase III double blind study testing whether fingolimod (0.5mg taken daily for three years) is effective in delaying disability progression compared to placebo in 951 people with primary progressive MS. The study is due to finish in September 2014.

How fingolimod works

Fingolimod works by binding to the surface of white blood cells (lymphocytes) in the immune system. This causes a large proportion of the lymphocytes to be retained in the lymph nodes, reducing the number that can reach the central nervous system and attack nerve cells in the brain and spinal cord.

In addition, there is evidence that fingolimod may have a direct effect on nerve cell damage and enhance the repair of myelin, which may have implications for people with progressive MS.


How is fingolimod given?

Fingolimod is taken orally as capsules.


Side effects and contraindications

Fingolimod causes a temporary bradycardia (decrease in the heart rate) and may be associated with atrioventricular block (a type of heart rhythm disorder). Following a formal safety review by the European Medicines Agency (EMA), guidelines are in place that mean people should take their first dose of fingolimod under medical supervision and have their heart rate and blood pressure monitored for at least six hours.

Other common side effects include headache, liver enzyme increases, influenza, diahorrea, back pain, and cough. Fingolimod may also cause macular oedema (a swelling in the eye affecting vision).


References

National Institute for Health and Clinical Excellence (NICE).
Fingolimod for the treatment of highly active relapsing-remitting multiple sclerosis.
NICE technology appraisal guidance 254.
Available from NICE website

Scottish Medicines Consortium (SMC).
Advice: fingolimod (Gilenya) - 10 September 2012.
Available from SMC website

Kappos L, et al.
Placebo-controlled study of oral fingolimod in relapsing multiple sclerosis.
New England Journal of Medicine 2010;362(5):387-401.
Read online

Cohen J, et al.
Oral fingolimod or intramuscular interferon for relapsing multiple sclerosis.
New England Journal of Medicine 2010;362:402-415.
Read online

INFORMS study
ClincalTrials.gov website

Brinkmann V, et al.
FTY720: sphingosine 1-phosphate receptor-1 in the control of lymphocyte egress and endothelial barrier function.
American Journal of Transplantation 2004;4:1019-1025.
abstract

Miron VE, et al.
Fingolimod (FTY720) enhances remyelination following demyelination of organotypic cerebellar slices.
American Journal Pathology 2010;176:2682-2694.
Read online


Patient Information Leaflet

Gilenya (EMC website)

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