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daughter



Joined: 08 Apr 2009
Posts: 4
Location: Wisconsin

Post Posted: Fri Apr 24, 2009 7:27 am Reply with quote    Back to top    

My family (and friends and congressmen and etc, etc, etc) have been in contact with both the FDA and InterMune, the company that is working on Pirfenidone. They have submitted the NDA to the FDA on a fast track for the drug. There is not YET a "compassionate use" program for current pulmonary patients. What they told my mom is that the "compassionate use" program may be up and running "by the end of the summer", but with no further clarity than that.

We are trying to stay on top of this whole thing with Pirfenidone as my dad's pulmo says he couldn't make the trip to Japan.

Good luck, and keep the faith.

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Mercy



Joined: 20 Aug 2008
Posts: 49

Post Posted: Sat Apr 25, 2009 9:01 pm Reply with quote    Back to top    

Drug for Deadly Lung Disease Shows Promise
Idiopathic pulmonary fibrosis kills 40,000 Americans each year
By E.J. Mundell
HealthDay Reporter
,
HEALTHDAY
posted: 338 DAYS 2 HOURS AGO
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FRIDAY, May 23 2008 (HealthDay News) -- Patients with a progressive fibrosis of the lungs that's fatal within a few years of diagnosis may finally have some reason for hope.
Japanese researchers say daily use of the drug pirfenidone improved the lung function and lengthened the survival of patients with the illness, called idiopathic pulmonary fibrosis (IPF).
"Patients look to any research in IPF with a sense of hope, because right now, there's very little that can be done for them," said Mark Shreve, founder and chief operating officer of the Coalition for Pulmonary Fibrosis, based in San Jose, Calif.
"To say that there's a desperate need -- even that would be an incredible understatement, because you are talking about a devastating, relentless disease that has a survival rate of less than three years, and no proven cause and no treatment," he said.
But the results of the new phase III clinical trial, involving 275 Japanese patients with mild-to-moderate IPF, may change all that. The findings were presented this week at the annual meeting of the American Thoracic Society, in Toronto.
According to Shreve, 128,000 Americans are battling IPF at any given time. Each year, 48,000 new cases are diagnosed, and 40,000 people die from the illness -- equal to the annual death toll from breast cancer.
IPF's origins remain largely unknown. It typically arises in late middle-age or the senior years and involves a progressive fibrosis: a process in which healthy lung tissue turns into useless scar tissue. This hardening of the lungs gradually and relentlessly robs patients of their ability to breathe.
"There's no drug, period, that's ever been approved for IPF," Shreve said. "Right now, the only treatment option that's been shown to extend the lives of patients is a lung transplant. But, other than that, the disease itself is an incredibly progressive, severe relentless disease."
That's why the results of the new trial have generated a level of cautious excitement among the IPF research community. In the study, a team led by Dr. Takashi Ogura, of Kanagawa Cardiovascular and Respiratory Center, Yokohama, gave patients either high-dose (1,800 milligrams) or low-dose (1,200 milligrams) pirfenidone or a placebo each day. Then they tracked changes in lung capacity, disease progression and patient survival over the course of a year.
Ogura's team reported that patients on high-dose pirfenidone achieved significantly less deterioration in lung capacity compared to those not on the drug. Those placed on the medication also displayed a slowdown in disease progression. Side effects included skin rash and loss of appetite.
"Taken together, our study demonstrated positive clinical effects of pirfenidone that suppresses the progress of IPF and potentially contributes to improving the outcomes of patients with IPF," Ogura said in a prepared statement.
Pirfenidone is "a drug in its own class," explained Dr. Ganesh Raghu, director of the Interstitial Lung Disease/Sarcoid/Pulmonary Fibrosis Program at the University of Washington Medical Center, in Seattle. His team pioneered the use of pirfenidone -- which is thought to have anti-inflammatory and anti-fibrotic properties -- against IPF more than a decade ago.
"It has taken this long -- 11, 12 years -- for it to reach the stage of phase III. I'm quite pleased that a drug of potential efficacy or anti-fibrotic effect is used for IPF. The Japanese trial is encouraging," said Raghu, who is also professor of pulmonary and critical care medicine at the University of Washington.
Still, he stressed that the population used in the Japanese trial may not represent the full spectrum of IPF patients, so it's too early to tell if pirfenidone will work for everyone with the disease. A larger, multi-center trial using the drug is currently under way in Europe and North America, with results expected later this year.
"Until further studies that enroll large number of patients and include all spectrum of patients with IPF, we cannot extrapolate the findings to the entire patient population with IPF," Raghu said.
He also cautioned that pirfenidone has not yet been approved for use against any medical condition by the U.S. Food and Drug Administration, meaning that IPF patients can only get the medicine by participating in a clinical trial.
And while pirfenidone may slow the progression of IPF, it does not stop it, Shreve noted.
"If this drug works out, that's fantastic, but it's still not a cure," Shreve said. "With a cure -- that's when we'll be really excited."
More information
To learn more about IPF, visit the Coalition for Pulmonary Fibrosis.
SOURCES: Mark Shreve, founder and chief operating officer, Coalition for Pulmonary Fibrosis, San Jose, Calif; Ganesh Raghu, M.D., professor, medicine and laboratory medicine, pulmonary and critical care medicine, and director, Interstitial Lung Disease/Sarcoid/Pulmonary Fibrosis Program, University of Washington Medical Center, Seattle; May 20, 2008, presentation, American Thoracic Society's annual meeting, Toronto

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Ken Fehr



Joined: 28 Apr 2009
Posts: 1

Post Posted: Tue Apr 28, 2009 8:15 pm Reply with quote    Back to top    

Please note that I just joined the organization today;however, I have been following pirfenidone for several years. I was originally selected to participate in the most current phase of clinical analysis. Somehow or another I was turned down by either the Drug Company or the participating hospital. I was quite excited last year when I heard that some good results came out of the last phase and that the drug Company was on a fast track with the FDA. I did not know that Japanese regulatory agency spproved the drug in Japan, Taiwan and Korea. I checked with the Pulmo at a large midwest Clinic and he told me that they were treating the last participants in the experimental stage with the drug; however, he did not know the FDA schedule and it would appear that I would have to go to Japan to be treated. He did not give me a name of an English speaking Doctor, but any large hospital in Japan would give a listing of Englisg speaking Doctors. He felt that I would have a problem with my oxygen requirements on the long flight....................Ken

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Joined April 2009 Have IPF since 2005
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Melissajoy



Joined: 21 Sep 2009
Posts: 28
Location: United Kingdom

Post Posted: Sun Sep 27, 2009 4:42 pm Reply with quote    Back to top    

Hi Anna,
I have just been diagnosed with IPF. I live on the Welsh borders!
I am going to find out as much as I can about Pirfenidone. My daughter is just starting her PhD at Imperial and I have found an old friend who is a professor in Immunology there, so she may be able to help with information. Will keep you posted.
Melissa
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Anna



Joined: 16 Feb 2003
Posts: 221
Location: Wild and Wonderful Wales

Post Posted: Tue Sep 29, 2009 3:55 am Reply with quote    Back to top    

Melissa, please email asap - annakingram@gmail.com. We have the Welsh borders in common, as well as other things, I think!
Anna x

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AL



Joined: 22 Oct 2009
Posts: 20

Post Posted: Thu Oct 22, 2009 6:37 pm Reply with quote    Back to top    

Hi all. I rang Shiniogi who told me you needed to get seen by a pulmo in Japan - no surprises there. Has anyone else been able to source this from elsewhere. I read a mention of one person suggesting Hong Kong and someone else said they got it for their wife?

thx

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strayze
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Joined: 22 Dec 2002
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Post Posted: Fri Oct 23, 2009 7:39 am Reply with quote    Back to top    

Below is the up-to-date statement of Intermmune, the company that owns pirfenidone rights, which says current development is in FDA's court. I've searched around on the FDA site on any publicly available info on their testing of pirfenidone, but could find nothing.


"Description

Pirfenidone is an orally active small molecule drug that may inhibit collagen synthesis, down regulate production of multiple cytokines and block fibroblast proliferation and stimulation in response to cytokines. Pirfenidone has demonstrated activity in multiple fibrotic conditions, including those of the lung, kidney and liver.

Investigational Activity

Pirfenidone for idiopathic pulmonary fibrosis (IPF) has been studied in multiple Phase 2 and three Phase 3 clinical trials. InterMune has completed the 779-patient Phase 3 CAPACITY program, which evaluated pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF). IPF is a chronic, fatal lung disease characterized by inflammation and scarring of the lungs. Based on Phase 3 results reported in February 2009, InterMune plans to seek regulatory authorizations to market pirfenidone for the treatment of IPF in the United States and Europe.

Investigational, not an FDA approved product."

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strayze
IPF-UIP by VATS at Hopkins, 8/00
NSIP by VATS review+ new tets, Nat. Jewish 3/04
Severe symptoms 12/99
Dyspnea since '73
ILD by CXRs since '85
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AL



Joined: 22 Oct 2009
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Post Posted: Fri Oct 23, 2009 11:29 am Reply with quote    Back to top    

Thanks strayze. Seems like a real shame that a drug that can help thousands of people is not available yet despite trials having finished quite some time ago and it being quite obvious that although it is not a silver bullet, at the moment it is the best we have. I understand the need for regulations etc but really feel that given the urgent unmet demand for a drug in this area, there really needs to be some way of giving this drug to people asap who really do need it. In addition, sale of this in Europe is likely to be 6 months later than the US, which doesnt help either

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strayze
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Post Posted: Sat Oct 24, 2009 12:05 pm Reply with quote    Back to top    

I agree, the process of evaluation is painfully slow. With pirfenidone, it appears from Intermmune's statement, that several phase 3 trials have already been carried out, which is good. I suspect that approval will come in 2010, unless the scientific advisory groups FDA uses bring up issues of individual members, who are mostly scientists/physicians in the private sector. I used to work in the Drug Division of FDA, and believe me, things can crawl through the process slowly. If an advisor's question seems important, the FDA's drug management can cause more studies to be done. The ultimate decision comes from FDA, on recommendation of the scientific advisory group. I shall search FDA's files to see if any public advisory groups has been assigned to discuss and examine pirfenidone as a possible drug. Reports that come from these groups are public knowledge. Note: pirfenidone is being considered in conditions other than pulmonary fibrosis. It is the use of pirfenidone for PF that we are interested in. FDA's website is www.fda.gov

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strayze
IPF-UIP by VATS at Hopkins, 8/00
NSIP by VATS review+ new tets, Nat. Jewish 3/04
Severe symptoms 12/99
Dyspnea since '73
ILD by CXRs since '85
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dynasty



Joined: 22 Nov 2010
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Post Posted: Mon Nov 22, 2010 12:00 pm Reply with quote    Back to top    

hey my dad has been diagnosed with pulmonary fibrosis for a year now and has been sick on an off. I just wanted to know if there is any way that we can get Pirfenidone or when and if it will ever be available to people suffering in the United States with this lung disesase. Thanks in advance.

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dynasty



Joined: 22 Nov 2010
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Post Posted: Mon Nov 22, 2010 12:03 pm Reply with quote    Back to top    

I also heard that is available in the UK is that true?

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Mickpictures



Joined: 26 Oct 2010
Posts: 57
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Post Posted: Mon Nov 22, 2010 5:08 pm Reply with quote    Back to top    

Hi
Here is a link to the company in India you may have seen it already
Take care
Mick

http://www.cipladoc.com/html/respiratoryupdate/pirfenex_monograph.pdf

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Mickpictures



Joined: 26 Oct 2010
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Location: Somerset England

Post Posted: Mon Nov 22, 2010 5:13 pm Reply with quote    Back to top    

Hi again
Sorry forgot to send company link
Mick



http://www.cipladoc.com/html/respiratoryupdate/newintrocipla.htm

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strayze
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Post Posted: Mon Nov 22, 2010 6:58 pm Reply with quote    Back to top    

Thank you Mick.

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strayze
IPF-UIP by VATS at Hopkins, 8/00
NSIP by VATS review+ new tets, Nat. Jewish 3/04
Severe symptoms 12/99
Dyspnea since '73
ILD by CXRs since '85
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delamelanicon



Joined: 12 Oct 2010
Posts: 6

Post Posted: Mon Nov 22, 2010 10:31 pm Reply with quote    Back to top    

Hi All ..
Pirfenidione is available freely in major metros of India especially Mumbai.

U need to be seen or goet ur papers reviewed by either a Physician / Pulmo / any one in International Travel Medicine.

Majority of the doctors in Mumbai speak fluent English and are well versed in treating respiratory cases.

It costs Rs 280 for 10 tablets approx US $ 5 - 6.

Do consider it as a viable travel destination for pirfenidione if required.

Do mail me if further information is required.

By law in India, pharma companis cannot sell drugs directly to consumer, so u have to go through a doctor or a chemist for buyin drugs over the counter.
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