Hi Everyone,
Yesturday the FDA agree to review Celgene Corporation ‘s New Drug Application for Revlimid. This means that the next step is potentially accessibility to the medication, if approved.
I have composed a letter to the FDA encouraging them to approve the drug. I have provided it below. Please let me know if you would like me to attach your name or any neames of friends and families that might want to be a part of it. I think it is important to do this as I am sure many could benefit from its use. Next hurdle Exjade!
June X, 2005
Mr. Lester M. Crawford, D.V.M., Ph.D
United States Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
Dear Mr. Lester M. Crawford,
I am writing this letter to you on behalf of the many people affected by Myelodysplastic Syndromes (MDS). MDS is a potentially life threatening condition which prevents the bone marrow from producing healthy blood cells and instead produces poorly functioning and immature ones. It is estimated that in the United States alone, 20,000 to 30,000 new cases are diagnosed each year with that number expected to rise. In some cases MDS is associated with chromosomal abnormalities such as a 5q deletion and many cases can also progress into Acute Myeloid Leukemia (AML). Although there is no one treatment that is effective for those affected by MDS, novel drugs and combination therapies are continually being developed.
Revlimid (lenalidomide) is a treatment that has been developed by the Celgene Corporation. Revlimid has been identified through almost 30 clinical trials as being an effective therapy for MDS. A 115 person Revlimid study, headed by Dr. Alan List of the H.Lee Moffitt Cancer Centre in Tampa, Florida, produced results of a 66% reduction or elimination of blood transfusions in transfusion-dependent MDS patients. More significantly, the same study found that the most common genetic mutation (5q deletion) fueling the syndrome, diminished in 81 patients and vanished in 51. As Revlimid is a highly effective advancement in MDS therapy, there is an urgent need for Revlimid’s approval for use as a MDS treatment.
The purpose of this letter is to strongly encourage FDA approval of Revlimid. Approval would provide MDS patients with an improved treatment regime and lessen the need for transfusions and highly toxic alternative treatments. Revlimid also has the ability to help those MDS patients with a 5q deletion (where no other comparable treatment exists), thus extending and saving the lives of tens of thousands of people worldwide. On behalf of MDS patients everywhere, I implore your timely approval of Clegene Corporation’s New Drug Application for Revlimid, submitted April, 2005.
We have lost too many lives to the devastation of this disease family, friends and children included. Notable individuals such as U.S. Senator Paul Tsongas (D-MA); U.S. Rep. Joseph Moakley; Scientist Carl Sagan; Scientist Marie Curie; and Former First Lady Eleanor Roosevelt succumbed to MDS as well.
I trust your sincere regard for this matter and look forward to hearing from you.
Sincerely,
.
