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| Attention site users: This information is provided courtesy of Blackfan, a Yahoo! chat group. I have omitted the names of representatives to avoid a flood of email's and questions. This is for informational purposes only. ******Please scroll to the bottom for the most up-to-date information on Exjade****** My name is Leslie **** and I work here at Novartis Oncology in the Patient Advocacy Group. I was asked by Rebecca ****** to send you this press release which impacts your patient population. Novartis Oncology has filed regulatory submissions for Exjade, also known as ICL670, in the United States and the European Union (EU). As you know, Exjade is the first and only once-daily oral iron chelator for the treatment of chronic iron overload due to blood transfusions. Exjade has been granted fast-track status in the US and Switzerland. Priority review has been requested in the US. The regulatory submission includes data from more than 1,000 patients and this clinical trials program is the largest ever prospectively implemented for an investigational iron chelator. I hope that you will share this important news with others in the Diamond Blackfan Anemia community. Attached for your reference is a press release announcing the filing as well as an Exjade backgrounder. Please do not hesitate to contact me with any questions. Regards, Leslie Patient Advocacy Relations Background on Exjade Click Here Press Release on Filing of Exjade Click Here FDA Grants Priority Review to Exjade-June 22, 2005 Click Here Too Much Iron- Novartis Website Click Here *Acquired from Blackfan-A Yahoo! Group* 11-03-05 I am elated to report that Exjade, the first and only once-daily oral iron chelator, has been approved by the US Food and Drug Administration. Exjade has been approved for treatment of chronic iron overload due to blood transfusions in adults and children age two and older. As you are aware, Exjade is the only iron chelator administered as a drink compared to the current standard of care, which often requires a subcutaneous infusion lasting eight to twelve hours per night, for five to seven nights a week. It is expected that the approval of Exjade will greatly enhance the acceptance of iron chelation therapy, especially for children, and offer a new alternative to the burdensome continuous infusion therapy. I hope that you will share this very important and exciting news with others in the Diamond Blackfan Anemia community. Attached for your reference is a press release announcing this new FDA approval. Please do not hesitate to contact me with any questions or concerns. Regards, Leslie Leslie Fields Manager Patient Advocacy Relations 862-778-4839 Read the official release from Novartis Special Note: Additional Information To address the unique needs of, and provide support for, patients undergoing chelation therapy, Novartis is implementing an ongoing patient support program for all patients taking Exjade. The EPASS" (Exjade Patient Assistance and Support Services) network is designed to help physicians and their patients get the most out of treatment with Exjade. Through a single point of contact with specially-trained operators, patients will be able to fill their Exjade prescriptions, obtain coverage and reimbursement assistance and choose to receive proactive Exjade educational support. For information on the EPASS network in the U.S., patients or health professionals can call 1-888-90E-PASS [1-888-903-7277]. WARNING for EXJADE USERS -2007 See this article : http://www.alertnet.org/thenews/newsdesk/N22436056.htm |
| News on chelators (begins with older postings to newer postings) |
