Cooley's Anemia Foundation Applauds FDA Decision on ExjadeDistribution Source : U.S. Newswire
Date : Wednesday, November 02, 2005
National Desk, Health Reporter
Contact: Craig Butler of Cooley's Anemia Foundation, 800-522-7222 ext 204 or
c.butler@cooleysanemia.org; Web:
http://www.cooleysanemia.org
FLUSHING, N.Y., Nov. 2 /U.S. Newswire/ -- The Cooley's Anemia Foundation (CAF) applauded the U.S. Food and Drug Administration's decision today to approve the oral iron chelator Exjade for the treatment of transfusional iron overload.
"This is milestone for people with thalassemia," said Gina Cioffi, Esq., national executive director of the Cooley's Anemia Foundation, the non-profit organization that is the voice of the thalassemia community in the United States. Individuals with thalassemia, often called Cooley's anemia, require lifelong blood transfusions as often as every two weeks. As a result of these transfusions, iron accumulates in and causes severe damage to their organs, leading to premature death.
Cioffi explained that "before today, the only FDA-approved method of removing that dangerous excess iron was through subcutaneous infusion of the iron chelator deferoxamine. Patients are required to stick a needle in themselves and pump deferoxamine into their bodies for up to 12 hours, almost every night. This burdensome process has proven to have a pronounced negative impact on the effectiveness of the drug, resulting in increased life-altering complications. "
"Deferoxamine is a good drug, but its method of delivery creates obstacles that are insurmountable for a large portion of our patient population," Cioffi continued. "We think that the availability of an oral chelator can make a meaningful difference in both the quality and quantity of life for those patients."
"We hope that approval of Exjade is a beginning, not an end," Cioffi added. "Each thalassemia patient has his or her own specific needs. To meet those needs, doctors should have available several chelating options, so that treatment can be tailored in the most effective way possible."
Thalassemia is a fatal genetic blood disorder that disproportionately affects people of Mediterranean, Northern African, Middle Eastern, South Asian, Chinese and Southeast Asian descent. There is no cure for thalassemia, and the life expectancy for patients, even with treatment, is significantly below the national average. Individuals with thalassemia are susceptible to a wide range of complications, including heart and liver failure, diabetes, osteoporosis and blood borne infections such as hepatitis and West Nile Virus.
Founded in 1954, the Cooley's Anemia Foundation is the only national non-profit dedicated to fighting the genetic blood disorder thalassemia. The Foundation provides import patient services, funds crucial medical research and educates health care professionals, government officials and the public about thalassemia.
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