Fingolimod

Overview:

  • Also known as: Gilenya
  • Pharmaceutical Company:Novartis Pharmaceuticals AG
  • Route and Dose of Administration: Oral (once daily at 0.25 or 0.50 mg)
  • Type: Sphingosine 1-phosphate receptor modulator
  • Emerging Treatment for: Relapsing-Remitting Multiple Sclerosis for children and adolescents aged 10 to 18 years
  • Status: Approved for adults with RRMS, submitted to Health Canada for approval for children and adolescents (ages 10 to less than 18) with relapsing forms of MS (RMS).
How it Works

Fingolimod (Gilenya) reduces the frequency of MS relapses by preventing certain immune cells from reaching the central nervous system, where they could potentially attack myelin, the fatty substance that insulates nerves and helps them transmit impulses between the brain and the body.

Research and Results

PARADIGMS: Phase III Trial

PARADIGMS, conducted in 87 sites in over 25 countries, is a phase III, double-blind, clinical trial that enrolled 215 children and adolescents with MS between the ages of 10 and 18 to evaluate the safety and efficacy of fingolimod compared to interferon beta-1a. Participants were randomly assigned to orally receive either fingolimod (0.25 or 0.5 mg dependent on body weight) daily or an injection of interferon beta-1a weekly. The primary outcome measure was the annualized relapse rate. Secondary outcome measures included the number of new or newly enlarged lesions, gadolinium enhancing lesions and safety properties of fingolimod. Treatment with fingolimod resulted in an 82% reduction in the annualized relapse rate over two years compared to interferon beta-1a. Furthermore, there was a reduction in the number of new or newly enlarging lesions and gadolinium enhancing lesions with treatment of fingolimod.

Fingolimod was approved for the treatment of RRMS in adults in 2011 and has been submitted to Health Canada to expand its use in children and adolescents with RRMS by Novartis Pharmaceuticals AG.

Adverse Effects Reported

Side affects reported from the phase III clinical trial were similar to those reported in the adult population. The most common side effects included headaches, diarrhea, cough, flu virus infections, inflammation of the sinus, abdominal pain, back pain and pain in the extremities.

References

FDA approval of Fingolimod for pediatric MS

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