Navigation Links
FDA Approves Ferriprox to Treat Patients with Excess Iron in the Body
Date:10/14/2011

SILVER SPRING, Md., Oct. 14, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Ferriprox (deferiprone) to treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

Patients with thalassemia have excess iron in the body from the frequent blood transfusions (transfusional iron overload), a condition that is serious and can be fatal.  These patients also have a risk of developing liver disease, diabetes, arthritis, heart failure or an abnormal heart rhythm.  

The standard of care to treat transfusional iron overload is chelation therapy – chemical agents that are used to remove heavy metals from the body. Ferriprox is intended for use when chelation therapy is inadequate.

"Ferriprox represents the first new FDA-approved treatment for this disorder since 2005," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

The safety and effectiveness of Ferriprox is based on an analysis of data from twelve clinical studies in 236 patients. Patients participating in the study did not respond to prior iron chelation therapy.  Ferriprox was considered a successful treatment for patients who experienced at least a 20 percent decrease in serum ferritin, a protein that stores iron in the body for later use. Half of the patients in the study experienced at least a 20 percent decrease in ferritin levels.

The most common side effects seen in patients who received Ferriprox included nausea, vomiting, abdominal and joint pain, urine discoloration (chromaturia), a decrease in the number of white blood cells (neutropenia), and an increase in the level of a liver enzyme that may be indicative of tissue or liver damage at unsafe amounts.

The most serious side effect seen in about two percent of patients treated with Ferriprox was the development of agranulocytosis, a serious and potentially life-threatening reduction in the number of granulocytes (a type of white blood cell that fights infection).

The therapy is being approved under the FDA's accelerated approval program, designed to provide patients with earlier access to promising new drugs followed by further studies to confirm the drug's clinical benefit.

The accelerated approval program allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on an endpoint that is reasonably likely to predict a clinical benefit to patients, or on an effect on a clinical endpoint other than survival or irreversible morbidity (illness).

ApoPharma has agreed to several post-marketing requirement and commitments. One commitment includes further study of the use of Ferriprox in patients with sickle cell disease who have transfusional iron overload.

Earlier this year, the U.S. Department of Health and Human Services (HHS) launched the Sickle Cell Disease (SCD) Initiative bringing together HHS agencies to enhance the quality and quantity of SCD data, develop best practice guidelines and quality of care metrics, improve health care delivery and coordination of care for patients with SCD, facilitate approval of new medical products, and expand research on SCD.  The post-marketing requirement for further study of Ferriprox aligns with the goals of the SCD Initiative.

Ferriprox is marketed by ApoPharma Inc. of Toronto.

For more information:

FDA: Office of Hematology and Oncology Products
http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm

FDA: Spotlight on Drug Innovation – Update of FDA's novel drug approvals in 2011
http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm254242.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/4/2017)... Fix Inc. (" Fortuna "), a private, clinical-stage biotech ... need for embryonic and fetal stem cells by using direct ... Fortuna announced today the launch of its Scientific ... PhD; Father Kevin FitzGerald , S.J., PhD; Col. (R) ... Giordano , PhD. "We are excited and honored ...
(Date:5/4/2017)... 4, 2017  A new tight-tolerance microextrusion medical ... highly-engineered materials, is being launched by Natvar, a ... developed in recent years to service a wide ... applications. More expensive materials such as glass and ... due to their ability to consistently hold tolerances. ...
(Date:5/3/2017)... 2017  West Pharmaceutical Services, Inc. (NYSE: WST), ... drug administration, announced today that Fran DeGrazio ... and Diane Paskiet , Director, Scientific Affairs, ... on West,s expertise in the areas of safety ... providing commentary on updated industry guidance. ...
Breaking Medicine Technology:
(Date:5/23/2017)... Newport Beach, CA (PRWEB) , ... May 23, 2017 , ... ... Capital Partners was honored to serve earlier this month as a Guest Speaker and ... by the British Royal Family and Common Purpose. , Walter Schindler ...
(Date:5/23/2017)... ... May 23, 2017 , ... By all indications, and due to months of ... call for diligence, asking homeowners to scout for any open water sources that can ... the annoying buzz of mosquitos is the buzz associated with potential infections stemming from ...
(Date:5/23/2017)... ... May 23, 2017 , ... ... provider in the modern ART laboratory, to provide hands-on training utilizing cutting-edge equipment ... , NextGen LifeLabs, a MedTech Group Purchasing vendor , will provide specialized ...
(Date:5/23/2017)... ... May 23, 2017 , ... New patients from Charleston, ... an experienced dentist practicing in Mt. Pleasant, SC, with or without a referral. A ... for patients with missing teeth in Charleston, SC. Those who suffer from ...
(Date:5/23/2017)... (PRWEB) , ... May 23, 2017 , ... New patients ... and chronic bad breath, can now receive laser gum disease treatments from the doctors ... Campbell and David Landau are raising awareness of the importance of receiving qualified treatment ...
Breaking Medicine News(10 mins):