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Xiaflex Status
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02/08/2009 18:23
key 
02/08/2009 18:23
key 
Xiaflex Status

Does anyone know the current status of Xiaflex, I know the trials have compleated but curious as to when it will go to production??

03/03/2009 15:36
yankee21 
03/03/2009 15:36
yankee21 
Re: Xiaflex Status

Just read this article...........
http://www.marketwire.com/press-release/...UXL-956331.html

Here are the main parts:

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for XIAFLEX™ (clostridial collagenase for injection), a novel, first-in-class, orphan-designated biologic for the treatment of Dupuytren's contracture.

Auxilium has requested Priority Review designation for this BLA submission from the FDA. The Company expects to hear back from the FDA on Priority Review designation within approximately 60 days from the filing date. If granted, the FDA, per Prescription Drug User Fee Act guidelines, has up to six months from submission date to take action on the BLA. Priority Review may be granted to drug products that provide treatment when no approved pharmacological treatments exist for a disease.

Edited 03/03/09 18:12

03/03/2009 23:10
flojo 
03/03/2009 23:10
flojo 
Re: Xiaflex Status

Does anyone know the best way to apply pressure to the FDA for speedy approval? Should we all contact our Senators and Representatives?
I'm thinking that a coordinated effort would help.

03/04/2009 17:40
jwilly 
03/04/2009 17:40
jwilly 
Re: Xiaflex Status

I don't mean to be condescending but the decision should be scientific not political, with that said, politics sometime mixes into the F.D.A.'s decision making when it shouldn't.
J W

03/04/2009 18:52
myway53 
03/04/2009 18:52
myway53 
Re: Xiaflex Status

Thanks for the update on the Xiaflex Status. I'm anxious for this drug to hit the market but I'm left wondering if it's still 9 months to a year away.
Barbara

03/05/2009 00:30
flojo 
03/05/2009 00:30
flojo 
Re: Xiaflex Status

I agree that it should be a decision made by scientists. Getting Xiaflex on a fast track would not and should not compromise the efficacy of the study or the decision. It doesn't have to be political. Do you have any ideas?

Maybe contacting FDA with how it affects us would call attention to it and this study might be moved up in the pile so that it could be reviewed sooner.

There have been other drugs that have been expedited by the FDA because it was of a benefit to the public to get it to the market sooner rather later. Case in point,

"Clinical Review Herceptin@
BLA 98-0369
4.0 METHODOLOGY OF THE CLINICAL REVIEW - OVERVIEW
4.1 Clinical Studies
This Biologics License Application (BLA) for Herceptin@ was granted priority review
status and fast track designation; the sponsor was permitted to submit the contents in a
rolling fashion with a complete application filed on May 4, 1998. . ."

True, Dupuytren's is not life threatening as is breast cancer, but it would certainly be wonderful to soon have another alternative and very promising therapy for a lot of people with this debilitating disease.

03/05/2009 07:33
Wolfgang

not registered

03/05/2009 07:33
Wolfgang

not registered

Re: Xiaflex Status

Xiaflex is not a cure for Dupuytren's, it can't do significantly more than NA (though the recurrence period might be longer). If you have a bent finger today don't wait for Xiaflex, go and have NA.

Wolfgang

03/05/2009 16:57
drc8404 
03/05/2009 16:57
drc8404 
Re: Xiaflex Status

Does having NA done now preclude having Xiaflex treatments later?
Thanks

03/06/2009 07:23
Wolfgang

not registered

03/06/2009 07:23
Wolfgang

not registered

Xiaflex and NA

I can't see any conflict. NA only leaves a tiny scar and that shouldn't affect a later application of Xiaflex.

Wolfgang

Quote:



Does having NA done now preclude having Xiaflex treatments later?
Thanks


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