So many people thought that the Ice Bucket Challenge of summer 2014 was ridiculous and the money was going to line some CEO’s pockets. Well, naysayers, I give you this: Radicava (edaravone), a new drug for ALS treatment. The first new ALS specific drug to be approved in 20 years.
I am flabbergasted at the speed with which the FDA has approved this drug. The study was completed in 2014. That’s just 2 years and we’re in this with Europe’s version of the FDA. We are NEVER on the same time line as Europe with new drugs. I mean, NEVER EVER. Usually once a drug is approved in other markets, the FDA will require a study or two to be fully completed in all stages– taking the drug from rats, to biologically more human similar animals, to people trials– which can take around 20 years to complete. I really want to know the ALS’s community’s secret to getting this approved by the FDA without first having US performed research. The research that it’s been approved on looks pretty good. There were multiple promising sounding studies apparently, but one tipped the scale. It was done in Japanese, which I don’t read, but the English summaries make it sound pretty good– six month double-blind placebo controlled AND randomized (Cue the oooohhhs and ahhhhs…) over 13 years with 137 people. That’s not something to ignore.
It’s not yet available in your local pharmacy, but it’s looking like all the government paperwork will be completed and the stars will align in August. Hooray! Since this is a new drug it is still hugely expensive. It’s a daily IV infusion at about $1,000 a pop. *whistles* That’s a lot of money but, the pharmaceutical company has at least a little heart, saying they will help people to manage their co-pays, as if an insurance might pay any of it. Haha.
This still isn’t a cure. They’re saying they’ve gotten a 33% decrease in the rate of decline for the people that take this drug. Which doesn’t sound like much, but when there’s literally 1 other drug on the market and if that 1 doesn’t work for you…. They used the ALS Functional Rating Scale-Revised to determine that percentage. I, personally, had never heard of that scale, but it’s there in all it’s researched glory in the link for your purusing pleasure. Maybe I’ll read and post on that later on… stay tuned.