FDA Committee Schedules Meeting to Discuss Oral Chelator
July 26, 2011 – The Food and Drug Administration (FDA) announced today that it will discuss the New Drug Application (NDA) for the oral chelator Ferriprox (also known as deferiprone or L1) at a meeting of its Oncologic Drugs Advisory Committee (ODAC) on September 14, 2011.
Following standard FDA procedure, the Committee will subsequently recommend to the FDA whether Ferriprox should be made available for use in the United States, as it is in many other countries. (In the majority of cases, the FDA follows the recommendation of the Committees that review drug applications.) The proposed indication for Ferriprox is for the treatment of patients with transfusional iron overload when current chelation therapy is inadequate.
CAF believes that patients in the United States need more chelation options so that treatment can be tailored to the specific needs of each individual patient and supports this application. We encourage interested members of the thalassemia community to submit their views on the need for this oral chelator to the Committee.
Written submissions must be received by the FDA no later than August 30, 2011. Submissions should be submitted by mail to Caleb Briggs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Building 31, Room 2417, Silver Spring, MD 20993-0002; by email to ODAC@fda.hhs.gov or by fax to (301) 847-8533.
After sending your submission to the FDA, please forward a copy to us (Cooley’s Anemia Foundation, 330 Seventh Avenue #200, New York, NY 10001 or c.butler@cooleysanemia.org).