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:12/8/2016)... ANGELES , Dec. 8, 2016  Hanson ... manufacturing of dissolution testing and diffusion testing instruments ... been acquired by Teledyne Instruments, Inc. ("Teledyne"). The ... long-proven line of precision testing instruments, as well ... accelerating development of new products and services. ...
(Date:12/8/2016)... 2016  Haemonetics Corporation (NYSE: HAE ) has ... an innovative software suite designed to help customers drive efficiency ... of NextGen DMS 4 improves core features and introduces innovations ... liter of plasma collected, enhancing quality and regulatory compliance and ... ...
(Date:12/8/2016)... Inc . has announced regulatory approval by CFDA and product launch in ... (GERD). Continue Reading ... ... by Professor Jun Liu, Director of Endoscopy at Wuhan Union Hospital ... "We are very pleased that Mederi products are now available in ...
Breaking Medicine Technology:
(Date:12/8/2016)... PLAINS, N.Y., and JENNERSVILLE, Pa. (PRWEB) , ... ... ... to announce that Penn Medicine Southern Chester County, a Property owned by an ... The $23 million, 72,000 square foot Penn Medicine Southern Chester County ambulatory care ...
(Date:12/8/2016)... Boston (PRWEB) , ... December 08, 2016 , ... ... shareholders with global law firm Greenberg Traurig, LLP, will speak at DeviceTalks West, Dec. ... sponsor of the DeviceTalks series, and attorneys from the firm’s global Life Sciences & ...
(Date:12/8/2016)... N.J. (PRWEB) , ... December 08, 2016 , ... ... delivery technologies and development solutions for drugs, biologics and consumer health products, today ... PSCI was set up in 2006 as a non-profit organization to unite pharmaceutical ...
(Date:12/8/2016)... Peachtree City, Ga (PRWEB) , ... December 08, ... ... and moving as soon after surgery as possible. With this in mind, SIGVARIS ... vein thrombosis (DVT or blood clot) during bed rest and provide the benefits ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... services from offices headquartered in Hamilton County, is embarking on a charity drive ... specializes in finding new homes for orphaned or neglected senior dogs in the ...
Breaking Medicine News(10 mins):