Acorda Therapeutics’ Fampridine-SR likely to receive FDA app

If it's on your mind and it has to do with multiple sclerosis in any way, post it here.

Acorda Therapeutics’ Fampridine-SR likely to receive FDA app

Postby scorpion » Fri Oct 02, 2009 3:52 pm

Acorda Therapeutics’ (NASDAQ:ACOR) Fampridine-SR, a drug that is designed to improve walking ability in patients with multiple sclerosis, will likely receive FDA approval later this month, despite its increased risk for seizures, neurologists and a source close to the situation told Pharmawire.

FDA briefing documents will be available on 12 October. The company is expecting an FDA decision on 22 October.

But according to risk management consultants who previously worked at the FDA, the drug will likely receive a strict risk management (REMS) procedure and a black box warning for seizure risk.

Patients with multiple sclerosis will ultimately face difficulties with walking, as their disease progresses. In clinical trials, Fampridine-SR has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged.
User avatar
scorpion
Family Elder
 
Posts: 1323
Joined: Wed Nov 05, 2008 4:00 pm

Advertisement

Re: Acorda Therapeutics’ Fampridine-SR likely to receive FDA

Postby CureOrBust » Sat Oct 03, 2009 6:46 am

scorpion wrote:But according to risk management consultants who previously worked at the FDA, the drug will likely receive a strict risk management (REMS) procedure and a black box warning for seizure risk.
It must burn em a little that people who get it via compounding now, don't get the "black-box" warning.

Any info regarding how Fampridine-SR's release will effect the access to compounded versions of 4-AP? It will also be interesting to see the price difference.
User avatar
CureOrBust
Family Elder
 
Posts: 2914
Joined: Wed Jul 27, 2005 3:00 pm
Location: Sydney, Australia


Return to General Discussion

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: David1949


Contact us | Terms of Service