Canada Finally Approves Ferriprox.

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Offline Andy Battaglia

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Canada Finally Approves Ferriprox.
« on: February 18, 2015, 09:24:12 PM »
Canada has finally approved the iron chelation drug, Ferriprox, which has been on the market in India as Kelfer for 20 years+. It's about time they did what everyone else on earth has done and ignore Dr Nancy Olivieri and her questionable research. It is somewhat ironic that this drug, which was developed by Canadian company ApoPharma, is finally approved in the land where it was developed. How many patients died over the years while this drug was withheld is unknown, but it was far too many and included the founder of this group, who blamed Dr Olivieri for her coming death just a few months before she passed away.

http://www.newswire.ca/en/story/1488713/apopharma-announces-health-canada-approval-of-ferriprox-deferiprone
Quote
ApoPharma Announces Health Canada Approval of Ferriprox (deferiprone)
/NOT FOR DISTRIBUTION IN THE UNITED STATES OF AMERICA/

- Already approved in more than 65 countries worldwide, Ferriprox could become a new treatment option for Canadian patients with blood transfusion-related iron overload -

TORONTO, Feb. 17, 2015 /CNW/ - ApoPharma Inc., today announced that Health Canada has granted approval of Ferriprox (deferiprone), an oral iron chelator for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.

"We are very pleased that Health Canada has responded positively to the extensive clinical data and track record associated with Ferriprox," said Dr. Michael Spino, President, ApoPharma, Inc.  "This drug will provide a critically important new treatment option for individuals who have not had a good response with another therapy."

At any given time in Canada, approximately 400 patients with the inherited blood disorder thalassemia require blood transfusions for survival. While repeated blood transfusions are life-saving for many patients, they result in an accumulation of iron in blood and in organs such as the heart and liver. Without effective treatment, iron overload ensues and can lead to organ failure and early death.

Not all patients have their iron burden successfully controlled by the currently available treatment options. Approximately one quarter of thalassemia patients fall into this category, according to research conducted by the NIH-funded Thalassemia Clinical Research Network.

Clinical studies and more than 15 years of international post-marketing surveillance totaling approximately 58,000 patient years of exposure have demonstrated that Ferriprox can control the iron burden in patients who are transfusion dependent. In the pivotal clinical trial Ferriprox was twice as effective as deferoxamine in removing cardiac iron.  Analysis of studies sponsored by ApoPharma shows that one year of Ferriprox therapy met the targeted reduction of serum ferritin levels (a measure of total body iron) in approximately half of the patients who had failed previous therapy.

Ferriprox is currently approved in more than 65 countries worldwide for the treatment of iron overload in patients with thalassemia major when the standard therapy is contraindicated or inadequate. With the present approval, patients whose current therapy is unsatisfactory can be treated with Ferriprox as an established alternative.

One to two percent of Ferriprox patients develop agranulocytosis, a decline of certain white blood cells (neutrophils) that may put them at risk of serious infections.  ApoPharma is introducing a program designed to mitigate the potential risks among patients taking Ferriprox, similar to a program implemented in the US in 2011.

About ApoPharma

Headquartered in Toronto, ApoPharma Inc. is a pharmaceutical company specializing in the discovery and development of new medicines for critical diseases.  It is part of the Apotex Group of Companies, the largest Canadian-owned pharmaceutical company.

SOURCE Apotex Inc.
Andy

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Offline Nomad

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Re: Canada Finally Approves Ferriprox.
« Reply #1 on: February 19, 2015, 02:13:32 AM »
I can say, as someone who used to take it for 11 years and now again in a combination since 7-8 months that it's very good to see it finally granted. This was allways a good example about how a little mistake of a stubborn person can ruin something good for a very long time in cost of sick people. When she announced her results in 98 I was already taken it for over 3 years. I know the whole story...
Andy did you mean she passed away? (Dr.Oliviery?)

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Offline Dharmesh

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Re: Canada Finally Approves Ferriprox.
« Reply #2 on: February 19, 2015, 01:25:32 PM »
Dear Nomad,
Andy is talking about the founder of the group Liza.
Start listening your body, it always gives signs

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Offline Andy Battaglia

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Re: Canada Finally Approves Ferriprox.
« Reply #3 on: February 19, 2015, 03:14:39 PM »
Yes, Lisa had developed intolerance to desferal, and at the time, the only other chelator that was available was deferiprone (Ferriprox), but it was not available in the US. Lisa had been on a trial for Ferrirpox which was suddenly stopped because Dr Olivieri's findings purported to show that deferiprone caused the development of fibroids in the liver. Her research took place in the 1990's, when the use of Kelfer was growing quickly in India, as it was proved to have great chelation value. No other researcher has ever observed what Olivieri claimed and it is suspected that the patients all had fibroids before the trial began. A very basic truth was ignored. Correlation does not imply causation. Lisa felt that her last chance was Ferriprox and that chance had been taken away by the woman some call Dr No. Much of the story about Dr Olivieri's manipulation of the media to make herself look like a martyr can be found in the book, The Drug Trial by Dr Miriam Shuchman. The direct quote from Lisa Cammilleri several months before her death is "Dr Nancy Olivieri killed me." It remains a powerful statement today. I would not post this if it was not true, as Dr Olivieri has proven to be quite litigious over the years.
Andy

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Offline Nomad

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Re: Canada Finally Approves Ferriprox.
« Reply #4 on: February 19, 2015, 03:26:43 PM »
Oh, I got it now.  :dunno sorry my English is not perfect.
I had have 2 friends who didn't make it!
They passed away in 1995 because of very bad compliance with desferal and
Deferiprone wasn't available for them at that time …
You know, what I have never understand? The fact that she actually had never proved that it was a correlation between the liver inflammation and L1. And why the hell did nobody listen to all the other DR's who disagree with her! I know they exist because I tried at the same time to put others on L1...

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Offline Dharmesh

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Re: Canada Finally Approves Ferriprox.
« Reply #5 on: February 19, 2015, 06:13:59 PM »
It's sad to know about.
 :-\
Start listening your body, it always gives signs

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Offline jay

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Re: Canada Finally Approves Ferriprox.
« Reply #6 on: February 19, 2015, 07:26:14 PM »
It gave me chills. I read this couple of years back but now it is so clear to me.

Re: Canada Finally Approves Ferriprox.
« Reply #7 on: February 19, 2015, 08:50:49 PM »
I do recall the response I got when I asked the doctors in SickKids about Ferripox (That drug is not to be taken anywhere in the world). All of them were under her influence. Little Miss A had intolerence with Desferal for years until she developed Osteoporosis, but we didn't had any choice. Thankfully, Exjade came just in time for us.
Regards.

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Offline Nomad

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Re: Canada Finally Approves Ferriprox.
« Reply #8 on: February 19, 2015, 09:02:00 PM »
I've heard that she's been doing some co-work with Bangladesh Thalassaemics now. Don't know if it's true.

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Offline Andy Battaglia

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Re: Canada Finally Approves Ferriprox.
« Reply #9 on: February 19, 2015, 11:58:45 PM »
She has been active in Bangladesh. I find her to be an enigma. On one hand, she has done work in Asia on behalf of thals, which is truly a good thing. On the other hand, she allowed stubbornness to blind her to the reality that there was something wrong with her findings. The findings and real life observation of those using deferiprone never supported what she found. But beyond that, one of our senior members was basically abandoned by Dr O when our member's child developed a tough to treat problem. If not for this group, that member would have been left lost and without direction. I find abandoning patients unjustifiable.

Canadian Family, I remember that Exjade hit the market and gave you great relief. As I recall, there was concern about the effects of desferal on her hearing, as well.

I've seen too many patients die because the current chelators were not sufficient. I've seen patients like Ashish, Miaki and Gargi die because even with three available chelators, none suited them (although in the case of Ashish, it had more to do with an error in diagnosis by his doctor who took him off of Kelfer, than the chelator being unsuited for him). To see ego have block Ferriprox from approval is a stark lesson in human nature and the importance of being honest with ourselves. When no other research could duplicate the results Dr Olivieri claimed, and we had to take her word on that, as she refused to give her research to ApoPharma, the company that had commissioned and paid for that very research, then Dr O should have asked others to review her findings and then also be willing to review the research of others, which showed no fibroids being caused by the drug and the drug proving to be an excellent chelator of cardiac iron, as well as being cardioprotective. Ego is never more important than human lives.
Andy

All we are saying is give thals a chance.

Re: Canada Finally Approves Ferriprox.
« Reply #10 on: February 20, 2015, 02:29:06 PM »
Hi Andy,

You remembered correctly, there were concerns with hearing as well. Those were the days when exjade was not given to children below age of 5 in Canada, however, little miss A case was severe enough and we pushed for early admintration of exjade at age 4.

I hope ferripox continue to help thal patients around the world.

Regards.

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Offline Sharmin

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Re: Canada Finally Approves Ferriprox.
« Reply #11 on: February 21, 2015, 12:21:54 AM »
I am so glad that Ferriprox has been approved in Canada.

Canadian Family, I hope lil Miss A is doing well now.  How has her bone density been lately?

Wishing her the best,

Sharmin
Sharmin

 

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