I saw that too. The drug is shown to slow progression of ALS, a brutal and unmerciful disease, by 33%. The FDA's streamlining the process for approval is directly in line with the Cure's Act.
"Radicava is what's known as a free radical scavenger. It appears to react with nerve-damaging compounds generated as part of the disease process" ...... looks like another good combo to test 273 with .... (i.e. eliminate some of those nerve damaging compounds before hand)... Mitsubishi Tanabe is another huge Japanese pharma company in the CNS space... hopefully they are also on the rolodex at avxl ....
And what is similar is that drug for ALS, like Anavex, is a drug for a desease that is progressive,AND fatal, thus there is now precedent for the FDA to approve drugs that are in dire need, that have trials abroad.
“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” said Eric Bastings, M.D., deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.”
"The efficacy of edaravone for the treatment of ALS was demonstrated in a six-month clinical trial conducted in Japan. In the trial, 137 participants were randomized to receive edaravone or placebo. At Week 24, individuals receiving edaravone declined less on a clinical assessment of daily functioning compared to those receiving a placebo."
"The FDA granted this drug orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases."
Wow!!! did they fill the paperwork out for them too?
I can think of some other orphan designated drugs that have shown efficacy.
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