FDA Accepts Filing of ALS Drug EdaravonE

[GregK]

I noted this ~3 months back, but it got more press.

The FDA has accepted the New Drug Application (NDA) for edaravone (MCI-186) to treat amyotrophic lateral sclerosis (ALS). The PDUFA date — the day when a decision on the application is expected — is June 16, 2017.


FDA Accepts Filing of ALS Drug Edaravone

 

[GregK]

Story: Date set for Decision on Radicut as ALS Treatment in United States | ALS.net

 

[azgirl]

June 2017... Thanks a lot F DA

 

[lgelb]

They have to decide by that date to do something, even if it's asking for another trial. But they can decide before then.

Note responders in the last trial had at least 80% FVC, were at most 2y in and had at least 2 on every FRS item.

Meanwhile, PALS, esp. in early disease, might want to consider something like grape seed extract.

 

[diagnosed2016]

Why grape seed extract? I haven't read anything about that.

 

[gooseberry]

It is a powerful antioxidant which some believe relieves oxidative stress in the body.

 

[Manda]

So in reality, when do you think this drug is REALLY going to be avaliable for patients to try? Don't worry my hopes are never high.