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Gilenya (updated 4/20/2012)

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Gilenya was approved by the FDA in September 2010 for use in relapsing MS.
Update 4/20/2012:  The FDA and the EMA (European counterpart to the FDA) have conducted a safety review of Gilenya and issued updated recommendations on its use.  This is in response to a small number of unexpected deaths, which are most likely cardiac events.  This is a rare occurrence, as I am aware of 11 suspicious deaths reported, out of about 33,000 people on treatment.  It is unclear whether these events are related to Gilenya, but two events (one death and one transient loss of heart beat) happened in the first 24 hours after the first dose.  The updated recommendations include cautions about using Gilenya in people with defects in cardiac conduction or in people with previous heart attacks, strokes, or vascular disease.  They also recommend some changes in monitoring, including additional ECG. 
I continue to use Gilenya in selected patients with active MS, but I have discussed these events and risks with my patients.  Gilenya is an effective drug, but I am not using it as a first treatment or for people with mild disease. 

Gilenya is the new trade name for fingolimod.  It was previously known as FTY720.  It interferes with the movement of white blood cells around the body by blocking the receptor that they need to get out of the lymph node and into the blood.  It has good effectiveness in several clinical trials, including a study where it was compared to Avonex.  It is a pill rather than an injection or an infusion.  There are concerns about side effects, including infections, macular edema, cardiovascular effects, and possibly skin cancers. 
This drug has been in development for several years, and you can read about it at various stages in my reports from meetings elsewhere on this website. 
Because of the side effects and safety concerns, I am using this mainly for my patients with more severe MS.  Whether it ends up being a first-line or second-line choice for treatment will depend on the longer term safety results. 

J. William Lindsey, MD
University of Texas Multiple Sclerosis Research Group
Houston, Texas

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