Articles tagged with: Ferriprox
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The U.S. Food and Drug Administration (FDA) on Friday approved the drug Ferriprox for the treatment of iron overload in patients with thalassemia who have had an insufficient response to at least one other iron overload therapy.
Thalassemia is a genetic condition that causes anemia.
The FDA approval of Ferriprox (deferiprone), which will be marketed by the Canadian company ApoPharma, is in line with the recommendation the agency received from its Oncology Drug Advisory Committee, which met last month to review the drug (see related Beacon news).
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FDA Advisory Committee Recommends Ferriprox For Accelerated Approval – The pharmaceutical company ApoPharma announced last week that the Oncologic Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) recommended that the FDA grant accelerated approval to the iron chelation agent Ferriprox (deferiprone). Specifically, the advisory committee recommended that Ferriprox receives accelerated approval for the treatment of patients with blood transfusion-related iron overload when current chelation therapy is inadequate. The FDA normally follows the recommendations of its advisory committees but is not obligated to do so. Ferriprox has already been approved for the treatment of blood transfusion-related iron overload in Europe since 1999. Current treatment options for myelodysplastic syndromes (MDS) patients with transfusional iron overload include Desferal (deferoxamine) and Exjade (deferasirox). For more information, please see the Apotex press release.
Webinar: The Latest Developments In MDS – On September 29, the Aplastic Anemia & MDS International Foundation (AA&MDSIF) is hosting a webinar summarizing the main findings of the State-of-the-Science Symposium on MDS, which the National Institutes of Health held at the beginning of the month. Dr. David Steensma of the Dana-Farber Cancer Institute in Boston will lead the webinar, which starts at 3 p.m. ET. Dr. Steensma will talk about the implications of these findings for patients and their family members. Participants will have the opportunity to ask questions at the end of the webinar. For more information or to register, please see the AA&MDSIF website.
Free Conference For MDS Patients And Their Families – On October 1, the MDS Foundation will host a free one-day conference for MDS patients and their families in Boston. The conference will start at 10 a.m. with a patient support group discussion. In the afternoon, new therapies and treatment options for MDS will be presented and discussed. Complimentary breakfast and lunch will be served. For more information, please see the MDS Foundation website.
For a more detailed listing of MDS-related events, please check the MDS Beacon Events Calendar.
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Researchers from the Czech Republic recently found that Exjade is an effective and safe treatment for the removal of excess iron in lower-risk myelodysplastic syndromes patients. Additionally, their analyses indicate that Exjade may be more effective than Ferriprox in lower-risk patients who have high iron levels in the blood.
Dr. Jaroslav Cermak, lead author of the study, presented the results at the 2011 European Hematology Association (EHA) Congress in London.
Patients with myelodysplastic syndromes (MDS) may receive red blood cell transfusions to increase low red blood cell levels. Excess iron…
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The U.S. Food and Drug Administration’s (FDA) evaluation of Exjade (deferasirox) has concluded that the drug should not be prescribed to myelodysplastic syndromes (MDS) patients with poor prognoses or high-risk disease due to the possibility of liver or kidney impairment and gastrointestinal bleeding. It now requires Novartis, which markets Exjade, to include a highlighted “black box warning” in the prescribing information cautioning physicians and patients about its potentially serious or fatal side effects.
Exjade is an iron chelating agent that works to remove excess iron, which may have built up…
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Researchers Find Possible Gene Target for MDS Therapy - Researchers from the Van Andel Research Institute in Grand Rapids, Michigan, report that the gene RhoB plays an important role in the development of myelodysplastic syndromes (MDS). They found, in particular, that MDS progresses more rapidly when levels of the protein produced by RhoB are low. There is hope that examining RhoB levels in MDS advanced patients may help in the selection of the most appropriate treatments, and that future therapies will target this gene to prevent MDS progression. For more details, please see the related press release.
FDA Advisory Committee Set to Review Ferriprox - (See important update immediately below) On October 6, the U.S. Food and Drug Administration (FDA) Oncology Drugs Advisory Committee (ODAC) will review the iron chelating agent Ferriprox (deferiprone) for possible marketing approval in the U.S. Ferriprox is approved for sale in a number of countries outside of the U.S., and is used to treat iron overload in patients who require frequent blood transfusions. The meeting will include presentations by Ferriprox manufacturer ApoPharma Inc. and the FDA staff as well as questions from the public. The FDA usually follows the advice it receives from its advisory committees, but it is not required by law to do so. For more information, please see the meeting’s draft agenda and the Ferriprox Web site (intended for non-U.S. visitors).
Update: The FDA has announced that the Ferrirprox review meeting has been cancelled “to allow time for the FDA to review and resolve several outstanding issues.” The agency says that it intends to continue evaluating Ferriprox, and it will reschedule the ODAC meeting “as needed.”
Living With Myelodysplastic Syndromes One-Day Conference – The Moffitt Cancer Center and the Aplastic Anemia & MDS International Foundation (AA&MDSIF) are sponsoring a free opportunity to learn about the latest MDS diagnostic and treatment information, and ask questions of leading MDS researchers. This one-day conference will be on Saturday, October 10, at the Moffitt Cancer Center in Tampa, Florida, from 9 a.m. to 4 p.m. Breakfast and lunch are provided. Space is limited, so please register by October 2. For more information, please visit the AA&MDSIF Web site.
MDS Patient & Family Forum – Participate in a forum organized by the Myelodysplastic Syndromes Foundation on Tuesday, October 6, in Ontario, Canada. Dr. Karen Yee from Princess Margaret Hospital will be providing information pertinent to MDS patients and their families. Individuals must register by calling 1-800-MDS-0839 or emailing dmurray@mds-foundation.org. For a listing of other upcoming U.S. and international forums, please see the MDS Foundation Web site.
For a more detailed listing of MDS-related events, please check the MDS Beacon Events Calendar.