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|  |  Novarits Exjade(R) Receives First Approval Worldwide In The U.S.Press Release November 3, 2005 EAST HANOVER, N.J., Nov. 2 /PRNewswire/ -- Novartis announced today the first approval worldwide for ExjadeŽ (deferasirox) -- the first and only once-daily oral iron chelator -- by the U.S. Food and Drug A dministration. Exjade has been approved for the treatment of chronic iron overload due to blood transfusions in adults and children age two and older. Exjade is the only iron chelator administered as a drink (the tablets are dispersed in a glass of orange juice, apple juice or water), compared to the current standard of care, which often requires a subcutaneous infusion lasting eight to 12 hours per night, for five to seven nights a week for as long as the patient continues to receive blood transfusions or has excess iron within the body. As a result, many patients may have stopped or avoided iron chelation therapy, thus risking the toxic effects of iron overload. The approval of Exjade is expected to greatly enhance the acceptance of iron chelation therapy, especially for children, and offers a new alternative to the burdensome continuous infusion therapy. "The approval of Exjade is an advance for people like me, who have been having blood transfusions and iron chelation for most of our lives," said Jasmine Williams, who has sickle cell disease and participated in a clinical trial of Exjade. "With Exjade I won't have to worry about using my needle and pump. I just have to drink my medicine and not think about it again until the next day. Exjade has really made a difference in my life." Iron overload is a potentially life-threatening and unavoidable consequence of frequent blood transfusions used to treat certain types of rare chronic blood disorders, including thalassemia and sickle cell disease as well as other rare anemias and myelodysplastic syndromes. Signs of iron overload may be detected after transfusion of about 20 units of blood. If left undiagnosed or untreated, excess iron in the body is likely to lead to damage to the liver, heart and endocrine glands. The body has no inherent mechanism to remove excess iron, so iron chelation is used as an effective treatment for transfusion-related iron overload. "We believe Exjade is a significant breakthrough that will fill an important gap in protecting patients from the cumulative toxicity of iron overload by making iron chelation therapy much more acceptable. Until now, patients may have avoided the potentially life-saving benefits of iron chelation because the standard therapy can be difficult to use," said David Epstein, CEO of Specialty Medicines and President of Novartis Oncology. Exjade was approved after being granted priority review by the FDA and also after the Blood Products Advisory Committee to the FDA voted unanimously to give Exjade a positive recommendation for approval. Designated an orphan drug in the U.S., Switzerland, Australia, and the EU, Exjade has also been granted a priority review in Switzerland, Canada, Australia and New Zealand. Additional regulatory submissions have been made around the world. Filing data The Exjade filings were based on the results of a clinical trials program that included a Phase III trial, which showed that after one year Exjade produced reductions in liver iron concentration (LIC).
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