FDA Exjade Letter

[KP2112]

Hi Everyone,

Here is the letter regarding FDA approval of Exjade. I will be sending it on Monday July 11, 2005 with all the names that I have recieved. I think we might actually have around 100. Please let me know if you have any comments or if you have more names to add to our list. Again thank you for all your support.
Kind Regards,
Karen

Letter:

July 11, 2005

Mr. Lester M. Crawford, D.V.M., Ph.D
United States Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
USA

Dear Mr. Lester M. Crawford,

I am writing this letter on behalf of the many people affected by chronic iron overload due to the need of blood transfusions. Iron overload is a potentially life-threatening condition that results from frequent blood transfusions required to treat certain types of anemias and other disorders including: Myelodysplastic Syndrome (MDS), thalassemia and sickle cell anemia. If left undiagnosed or untreated, iron overload can lead to liver damage, affect other internal organs such as the heart and can also be fatal. Currently, people requiring a reduction in iron levels rely on a drug therapy called iron chelation with deferoxamine to remove excess iron from the body. This method however, requires the use of an uncomfortable and intrusive pump which is required for 8-12 hours, 5-7 days per week over a lengthy period of months or even years.

Exjade (ICL 670, deferasirox), developed by Novartis, presents itself as a significant advancement in the treatment of iron overload. The once daily oral iron chelation tablets are simply dispersed in water or orange juice then consumed. In Exjade clinical trials, the drug significantly reduced liver iron levels as opposed to today’s standard treatment with deferoxamine and an invasive pump. Exjade was also well tolerated as is evidenced through additional clinical trials in adults and children as young as two years of age.

As iron overload is a serious condition that affects thousands of people around the world, it is imperative the United States Food and Drug Administration (FDA) approve the use of Exjade for iron overload. Approval will decrease the burden in many people’s lives of having to utilize a pump for iron chelation and will also provide a new and acceptable treatment option for those avoiding the encumbrance of utilizing the current standard of care. Exjade is a straightforward treatment option which can only assist in advancing patient well-being and a greater quality of life.

On behalf of MDS and transfusion dependent patients everywhere, I implore your timely review and approval of Exjade, receiving FDA Priority Review commencing May 2005.

Please find attached a list of over 90 signatories supporting FDA approval of Exjade.

I trust your sincere and timely regard for this matter and look forward to hearing from you.

Sincerely,
Karen Pawlowski

[Suzanne]

Add my name! and thanks for your efforts.

[gemloyear]

Karen, An excellant and professionaly written letter, thank you. Ellie

[Bec]

Hey Karen,

Thank you for your letter and info. We were SO EXCITED to read about the drug approval. My Dad was on pump for 6 months. He was taken off of it when he got so sick last fall. Dr. just did ferritin test this week. I was working on computer with Dad trying to teach him how to get to site (have been trying for years HA) and we saw your letter.

Please add our names if still possible

Thanks again Becky Alford
Troy Alford
Bobby Bohler
Pat Bohler

[PhyllisA]

Dear Karen,

Please add our names to your letter and thank you for writing the letter.

Best wishes,
Ron and Phyllis Aemisegger

[cthomas555]

Good job.

Chris

[Kathryn]

Just wanted to thank you so much for your efforts!!

Best wishes to you,

Kathryn

[John in GR]

Thanks Karen,

Thanks so much for your very professionally written letter. We need to be pursuing help from all directions.

John

[KP2112]

Hi Everyone,

The Exjade letter was sent out yesturday. I think I had about 23 people on the list that I sent it to. I included organizations such as the Iron Disorders and Hemophilia Associations as well. I know that they are also concerned with iron overload.

Hope everyone is doing well. Although sometimes it seems things are at there worse they can always be worse. So try to stay positive and just enjoy every minute all the time.

Kindest thoughts to all,
Karen P.

[Dinesh]

I signed the letter eventhough I am late in signing.
My Ferritin level is 2530 after 12blood transfusions (2units each transfusion). Iam anxiously waiting fir Exjade FDA approval.

Dinesh Shah

[Dinesh]

I signed for Exjade approval letter eventhough I am late signing.
My Ferritin is 2530 after 12 blood transfusions ( 2units each). I am anxiously waiting for FDA approval. Thanks for taking the lead for letter.

Dinesh Shah

[stoli]

Thanks Karen for taking the time to write these support letters for all of us who are coping with this dreadful disease. I commend and thank you from the bottom of my heart.
Marvin

[Sandy L]

Great letter. You get an A+.

[Author]

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