Acorda Therapeutics Announces Positive Vote by FDA Advisory Committee for Fampridine-

[manouli]

Dr. Y oung, this must make you happy.




Acorda Therapeutics Announces Positive Vote by FDA Advisory Committee for Fampridine-SR
Tuesday, 13 October 2009 22:30



HAWTHORNE, N.Y.--Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs (PCNSD) Advisory Committee voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice daily demonstrated substantial evidence of effectiveness as a treatment to improve walking in people with multiple sclerosis (MS) and voted 10 to 2 (1 abstention) that it is clinically meaningful and can be safe for use.

“We are pleased with the outcome of today’s Advisory Committee meeting. People with MS have an urgent need for therapies to improve their walking, which is essential to conducting their activities of daily life. If approved, Fampridine-SR would be the first medicine to improve walking in people with MS,” said Ron Cohen, M.D., Acorda Therapeutics President and CEO. “This Advisory Committee meeting is an important milestone in the development of Fampridine-SR, and we look forward to working with the FDA as it completes its review of Acorda’s New Drug Application.”



more....

http://biomedreports.com/articles/ne...ridine-sr.html

[Wise Young]

Manouli,

It is with a sigh of relief that I greet this news. Approval by the advisory committee is only the first step of the final approval process. Getting 4-aminopyridine approved has been a longer and tougher road that any of us could have realized when we started on this road. The first clinical trials of 4-aminopyridine in multiple sclerosis were done in the 1980's. Andrew Blight discovered the effects of 4-aminopyridine in spinal cord injury in 1987 at NYU. The first phase 1 trials of the drug for spinal cord injury were carried out in the early 1990's. Acorda Therapeutics licensed the patent in 1997. Acorda's trials assessing 4-aminopyridine on spinal cord injury failed in 2006. Acorda resurrected Fampridine from almost certain death as a drug and showed that it is effective for multiple sclerosis. It took over 30 years to gather the evidence necessary to get formal FDA approval Fampridine as a safe and effective drug for multiple sclerosis.

Wise.

Originally Posted by manouli

Dr. Y oung, this must make you happy.




Acorda Therapeutics Announces Positive Vote by FDA Advisory Committee for Fampridine-SR
Tuesday, 13 October 2009 22:30



HAWTHORNE, N.Y.--Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced the U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs (PCNSD) Advisory Committee voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice daily demonstrated substantial evidence of effectiveness as a treatment to improve walking in people with multiple sclerosis (MS) and voted 10 to 2 (1 abstention) that it is clinically meaningful and can be safe for use.

“We are pleased with the outcome of today’s Advisory Committee meeting. People with MS have an urgent need for therapies to improve their walking, which is essential to conducting their activities of daily life. If approved, Fampridine-SR would be the first medicine to improve walking in people with MS,” said Ron Cohen, M.D., Acorda Therapeutics President and CEO. “This Advisory Committee meeting is an important milestone in the development of Fampridine-SR, and we look forward to working with the FDA as it completes its review of Acorda’s New Drug Application.”



more....

http://biomedreports.com/articles/ne...ridine-sr.html

[lynnifer]

Any guesses into how this translates into 'I go to my GP in Canada and he agrees to prescribe it as 'off-label' use?'

In other words, how long to market?

I know it only works on 1/3rd of those with spinal cord injury .. but being as how my paralysis was caused by Transverse Myelitis, I'm extremely curious as to whether or not I would see any effect. Even being flaccidly paralyzed.

Oh and uhh .. yes .. this is me in the backseat of YOUR car, Dr Young, whining, "How much longer!? Are we there yet!?"

[ValonOsmani]

Originally Posted by Wise Young

Manouli,

It is with a sigh of relief that I greet this news. Approval by the advisory committee is only the first step of the final approval process. Getting 4-aminopyridine approved has been a longer and tougher road that any of us could have realized when we started on this road. The first clinical trials of 4-aminopyridine in multiple sclerosis were done in the 1980's. Andrew Blight discovered the effects of 4-aminopyridine in spinal cord injury in 1987 at NYU. The first phase 1 trials of the drug for spinal cord injury were carried out in the early 1990's. Acorda Therapeutics licensed the patent in 1997. Acorda's trials assessing 4-aminopyridine on spinal cord injury failed in 2006. Acorda resurrected Fampridine from almost certain death as a drug and showed that it is effective for multiple sclerosis. It took over 30 years to gather the evidence necessary to get formal FDA approval Fampridine as a safe and effective drug for multiple sclerosis.

Wise.

Dr.Wise,

Is it possible that every drug or therapy which show promises treating or curing SCI in coming years need to go in such a hard and long process to win a FDA approval?

[Wise Young]

Originally Posted by ValonOsmani

Dr.Wise,

Is it possible that every drug or therapy which show promises treating or curing SCI in coming years need to go in such a hard and long process to win a FDA approval?

No, it should not have taken so long. However, first drugs of their class always take a long time. Fampridine is the first drug of its type and class, that improves conduction of demyelinated axons. Further drugs of this class will have an easier time.

Wise.

[filbert2]

fingers crossed!

[MSWIFE1]

Acorda submitted more info so now the FDA pushed it back to Jan 22, 2012.

[DA]

if 4-ap was a sex drug, would it had taken this long?
you cant trust the fda.

[znop]

whether you you agree or disagree with the FDA process it still runs the SHOW!!!
I have been telling you this DA for the last ten years. when are you going to pay your losing bet?? I got 10 grand coming my way lol. You said the cure would be here by 2000. I have always stated that until some drug or therapy is in the phase 3 trial there is nothing to get excited about. And a cure will only come about using combination therapies which is still years to decades away.

pay me or have a giant sci party down there in texas and invite all sci's. You buy the beer and food lol

you know I am just kidding, but you should not bet when you know I am right and you are usually wrong

[DA]

Originally Posted by znop

whether you you agree or disagree with the FDA process it still runs the SHOW!!!
I have been telling you this DA for the last ten years. when are you going to pay your losing bet?? I got 10 grand coming my way lol. You said the cure would be here by 2000. I have always stated that until some drug or therapy is in the phase 3 trial there is nothing to get excited about. And a cure will only come about using combination therapies which is still years to decades away.

pay me or have a giant sci party down there in texas and invite all sci's. You buy the beer and food lol

you know I am just kidding, but you should not bet when you know I am right and you are usually wrong

i was talking science. the science to cure sci is here. however the politics, the greed, the red tape, the apathy keeps us from having it.