Re: Perfinedone application made to the FDA

[Guest guest]

Does anyone know how long it takes for approval - are we looking at months, or years? Dorothy Reinecke

UIP-7/05

To: Breathe-Support Sent: Thu, November 5, 2009 9:37:47 AMSubject: Perfinedone application made to the FDA

I don't know if it's new news, but it is to me. Intermune has applied for a new drug approval for Perfinedone as a treatment for pulmonary fibrosis. I was alerted to that by the coalitionforpf. org I'll check with my pulmo guys and see what that means, if anything. Some time ago I asked them about the drug, having heard it was in testing, and didn't get much of a rise out of anybody, so I dunno.

Bill C. IPF 10/08

N.E. PA

[Guest guest]

Dorothy

It could take from months to forever as there is certainly no certainty

it will be approved. While I believe there's a good chance it will be,

the facts are that the clinical trials ultimately showed little if any

benefit. While there was some advantage on one of the trials and not on

the other at the 36 week mark or so, the other trial had none. And both

trials were consistent in showing no difference between the drug and the

placebo at 72 weeks in either function or death rate. In addition the

drug did have a wide range of side effects. I'm sorry that it didn't

turn out to be more than it did. I'm sure some doctors will widely

promote it's use, especially those who have received stipends for

speaking and consulting from Intermune and who also promoted Actimmune.

The doctors in other areas, including those in my area, have expressed

no interest in prescribing Pirfenidone.

If it's approved, whether to take it or not will be an individual

decision. I just hope those with treatable conditions like NSIP and HP

and Connective Tissue Disease caused PF don't forego other meds for this

one. Also, understand the test group was a very narrow demographic. It

was mostly male, mostly older, all IPF (UIP with no known cause), and

all very early stage.

As much as we all want a treatment, we just need to be cautious. This

application submission is running about 10 months behind Intermune's

projection. Only time will tell how long the FDA will take or what the

ultimate outcome will be.

The good news is that there are many many more trials underway for other

drugs. So hope continues. Meanwhile there are things we all can continue

to do to take care of ourselves the best possible, depending on our

individual circumstances.

>

> Does anyone know how long it takes for approval - are we looking

at months, or years?

> Â Dorothy Reinecke

>

> UIP-7/05

>

>

>

> ________________________________

> From: " Paradis3@... " Paradis3@...

> To: Breathe-Support

> Sent: Thu, November 5, 2009 9:37:47 AM

> Subject: Perfinedone application made to the FDA

>

> Â

> I don't know if it's new news, but it is to me. Intermune has

applied for a new drug approval for Perfinedone as a treatment for

pulmonary fibrosis. I was alerted to that by the coalitionforpf.

org I'll check with my pulmo guys and see what that means, if

anything. Some time ago I asked them about the drug, having heard

it was in testing, and didn't get much of a rise out of anybody, so I

dunno.

>

> Bill C. IPF 10/08

> N.E. PA

>

[Guest guest]

Bill,

Good to hear from you. I was thinking that I hadn't seen you on the board for some time and was getting a little worried. Hope all has been well.

AB

Subject: Perfinedone application made to the FDATo: Breathe-Support Date: Thursday, November 5, 2009, 9:37 AM

I don't know if it's new news, but it is to me. Intermune has applied for a new drug approval for Perfinedone as a treatment for pulmonary fibrosis. I was alerted to that by the coalitionforpf. org I'll check with my pulmo guys and see what that means, if anything. Some time ago I asked them about the drug, having heard it was in testing, and didn't get much of a rise out of anybody, so I dunno.

Bill C. IPF 10/08

N.E. PA