News for the Multiple Sclerosis Community

Oral MS Drug Fingolimod Retains Effectiveness Over 3 Years

More than two thirds of patients with MS taking the experimental oral drug fingolimod (FTY720) have remained relapse free for at least 3 years, researchers reported at the AAN.

The sustained benefits of fingolimod were seen among patients in an open-label extension trial of a phase 2 trial of the drug. Very good news indeed!

I know this is speculative, but what is the to-market time frame and process for a drug like Fingolimod? Is it in final testing right now before going through complete approval? Are we 2 years out in terms of having it available on the market? 4 years?

The optimism this drug is providing both in terms of reduced relapse rate and the oral aspects can't be understated. :)

art's picture

The last paragraph in this story says they are hoping for approval in 2009.

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Art Mellor, Accelerated Cure Project for MS, art-msnews -at- acceleratedcure.com

What is the time between "submitting for approval" and actual market availability usually? I don't suspect that is a quick process.

If they "fast track" it, it could as little as six months for approval, and market availablity shortly thereafter.

I don't want to be a party pooper, but tysabri and vioxx were fast tracked too, we know how that turned out.

My neuro has said that thanks to the tysabri debacle, he won't routinely use any MS drug without at least several years of post approval data.

If fingolimod is fast tracked that would be great but will it eventally be on the PBS list & if so how long does that take? I'm guessing fingolimod may not be affordable to most who need it without the PBS.