First ORAL Therapy: Gilenya (FTY720, Fingolimod) Moves Closer to FDA Approval!

Great news for those living with MS!  The FDA advisory committee reviewed Gilenya (fingolimod, FTY720) today.  The 25 members of the committee all found that the clinical trials had demonstrated substantial effectiveness of Gilenya and safety data justifies approval.  The vast majority on the committee also voted to allow use of the drug as a first option rather than restrict it only as a second option.  Monitoring recommended for slow heart rate risk with first dose.  Swelling in the back of eye (macular edema) and potential lung function evaluations were supported by the committee members.

The MS Center for Innovations in Care was the only center in St. Louis to participate in the relapsing remitting trials TRANSFORMS and FREEDOMS 2 for FTY720.