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Gilenia recommended for approval by the FDA Advisory committee 6/10/10.

Gilenia 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. 
Approval by the FDA advisory committee is only the first step to availability.  It still needs final approval by the FDA, and may be marketed near the end of this  year. 
Because of the side effects, I will probably start 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

copyright 2007-2010 John William Lindsey