Acorda Therapeutics Inc (ACORQ)

[Schekin]

We're almost there!! from October 22nd...
The PDUFA date was extended to January 22, 2010
from http://sci.rutgers.edu/forum/showthread.php?t=129680
an ACOR director,
"...Everybody is waiting with baited breath for the PDUFA agreement.

PDUFA stands for Prescription Drug Use Fee Act which was first enacted in 1992 and then revised in 1997 and 2002, under which the pharmaceutical industry agrees to pay fees to the FDA in exchange for performance standards that the FDA agrees to meet. The funds are used to fund the FDA process for approving new drugs. At the present time, the fees are $1,178,000 for a full application requiring clinical data and $589,000 for applications not requiring clinical data.

Since the enactment of PDUFA, the time required for FDA approval of new drugs have fallen dramatically by 51% (Source) Typical times for approval were around 100 months before the passage of PDUFA and fell to close to 50 months in recent years. I am not sure of the approval time for Fampridine but I believe that the application was submitted in January or February of 2009. In other words, it took less than a year. The time for approval is measured from the time that the FDA receives the application and the time when the PDUFA approval is granted.

There are several types of PDUFA actions (Source). First, they can approve. This is of course what everybody hopes for. Second, they can extend the PDUFA date. Although infrequently done, this may occur if the sponsor submits new data that is substantial. Third, they can issue a non-approval letter.

Prior to PDUFA action, there is the FDA advisory committee. In Acorda's case, the FDA Peripheral and Central Nervous System Drugs Advisory Committee voted (12 to 1) on October 22 to approve fampridine sustained release at 10 mg twice daily for symptomatic improvement of walking ability in patients with multiple sclerosis. The committee also voted (10 to 2 with 1 abstention) that the improvement is clinically meaningful and the drug can be safe for use (Source). Finally, the committee voted 12 to 1 that the company be required to study doses lower than 10 mg before approval. Because of the new data requirement, the PDUFA date was extended to January 22, 2010.Everybody is waiting with baited breath for the PDUFA agreement.

PDUFA stands for Prescription Drug Use Fee Act which was first enacted in 1992 and then revised in 1997 and 2002, under which the pharmaceutical industry agrees to pay fees to the FDA in exchange for performance standards that the FDA agrees to meet. The funds are used to fund the FDA process for approving new drugs. At the present time, the fees are $1,178,000 for a full application requiring clinical data and $589,000 for applications not requiring clinical data.

Since the enactment of PDUFA, the time required for FDA approval of new drugs have fallen dramatically by 51% (Source) Typical times for approval were around 100 months before the passage of PDUFA and fell to close to 50 months in recent years. I am not sure of the approval time for Fampridine but I believe that the application was submitted in January or February of 2009. In other words, it took less than a year. The time for approval is measured from the time that the FDA receives the application and the time when the PDUFA approval is granted.

There are several types of PDUFA actions (Source). First, they can approve. This is of course what everybody hopes for. Second, they can extend the PDUFA date. Although infrequently done, this may occur if the sponsor submits new data that is substantial. Third, they can issue a non-approval letter.

Prior to PDUFA action, there is the FDA advisory committee. In Acorda's case, the FDA Peripheral and Central Nervous System Drugs Advisory Committee voted (12 to 1) on October 22 to approve fampridine sustained release at 10 mg twice daily for symptomatic improvement of walking ability in patients with multiple sclerosis. The committee also voted (10 to 2 with 1 abstention) that the improvement is clinically meaningful and the drug can be safe for use (Source). Finally, the committee voted 12 to 1 that the company be required to study doses lower than 10 mg before approval. Because of the new data requirement, the PDUFA date was extended to January 22, 2010."