Oral MS Drug Moves Forward at FDA

Fingolimod (aka Gilenia, FTY720) got a unanimous thumbs-up from an FDA advisory committee on June 10th, sending it along the path for formal FDA approval, which will probably happen in September of this year.

Fingolimod is one of the oral disease-modifying therapy candidates for multiple sclerosis (MS) in the pipeline, and the one that is closest to hitting the market.

The advisory committee recommended:

• Fingolimod be approved at the 0.5 mg dose (the dosage recommended by Novartis)
• Fingolimod be used as a first-line drug
• that the FDA require post-marketing studies and further research on potential side effects, and possible interactions with other drugs that people with MS might take (like Solu-Medrol for relapses)
• further research be done to see if even lower doses would be just as effective
• a patient monitoring program be put in place to watch for heart problems (like possible lowering of heart rate) during the first dose
• patients be assessed (before starting therapy, I think) and monitored for eye problems, like macular edema, and lung issues

Again, this does NOT mean that fingolimod is available now. It means that this committee looked at all aspects of this drug and recommends that the FDA approves it (the agency usually does follow these recommendations).

In case you were wondering, there seems to be a great deal of name confusion around fingolimod, with some reporting that the name "Gilenia" (see Gilenia = Fingolimod) was rejected by the FDA and the drug is currently without a brand name.

If you want to know more about the oral drug candidates from me, read What's Up With Oral Drugs for Multiple Sclerosis?

Other sources do a great job at giving more detail about this committee recommendation and fingolimod itself. Here are a couple to start with:

UPDATE: FDA Panel Recommends Approval of Oral Fingolimod for Relapsing MS - If ngency follows advice, it would become the first oral disease-modifying therapy for MS

the non-shot heard round the world (in multiple sclerosis)