Corporate Banner
Satellite Banner
Pharma Outsourcing
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Injectafer® Receives US FDA Approval for the Treatment of Iron Deficiency Anaemia

Published: Monday, July 29, 2013
Last Updated: Monday, July 29, 2013
Bookmark and Share
Injectafer® has received US Food and Drug Administration (FDA) approval for the treatment of Iron Deficiency Anaemia (IDA).

Luitpold Pharmaceuticals, Inc., the US partner of Vifor Pharma, a company of the Galenica Group, will immediately launch the product. Injectafer® will be produced at the Luitpold manufacturing facility in Columbus, Ohio.

Injectafer® (US brand name of Ferinject®, ferric carboxymaltose) has received US Food and Drug Administration (FDA) approval for the treatment of Iron Deficiency Anaemia (IDA) in adult patients who have had an unsatisfactory response to oral iron or who have intolerance to oral iron.

Injectafer® is the first non-dextran intravenous iron therapy to gain US FDA approval for the treatment of IDA in a diverse group of patients with this debilitating condition, irrespective of the underlying origin. Injectafer® is also indicated for Iron Deficiency Anaemia in adult patients with non-dialysis dependent Chronic Kidney Disease (ND-CKD).

The approval is based on the evaluation of two large, multi-centre, randomised, controlled clinical trials conducted by Luitpold Pharmaceuticals, Inc. that studied more than 3,500 patients, of which approximately 1,800 were treated with Injectafer®. Both trials met their efficacy and safety endpoints and were presented at the American Society of Nephrology’s (ASN) Kidney Week 2011. The results of the VIT 31 study were recently published in the peer-reviewed journal “Transfusion”; results from the VIT 30 study (REPAIR-IDA trial) are anticipated to be published in another peer reviewed medical journal in the near future.

Luitpold Pharmaceuticals, Inc., the Vifor Pharma partner in the United States, will immediately launch Injectafer® to provide this important new drug to US physicians and their patients. In the US market, the product is available in 750mg vials and will be produced at the Luitpold manufacturing facility in Columbus, Ohio.

In the United States there are an estimated 7.5 million people with IDA, a condition that occurs when body iron stores are inadequate for normal red blood cell production. IDA is a frequent complication in many gastro-intestinal disease states and conditions, affecting up to one-third of inflammatory bowel disease patients, and up to 24% of patients undergoing bariatric bypass surgery. It is also prevalent in children and women, with over 3 million US women of childbearing age affected due to conditions such as heavy uterine bleeding, postpartum anaemia and pregnancy.

Ferinject® was approved by both the Swiss regulatory agency Swissmedic and the UK Medicines & Healthcare products Regulatory Agency (MHRA) in 2007. With the UK as Reference Member State, the MHRA has supported the subsequent approval of Ferinject® throughout the European Union. Ferinject® is currently registered for use in 46 countries and has been launched in 37 markets worldwide.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,900+ scientific posters on ePosters
  • More than 4,200+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.


Scientific News
Therapy Halts Progression of Lou Gehrig’s Disease
Researchers at Oregon State University announced today that they have essentially stopped the progression of amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, for nearly two years in one type of mouse model used to study the disease – allowing the mice to approach their normal lifespan.
New Mechanism of Antitumor Action Identified
A team of UAB researchers and collaborators from the Catalan biotech company Ability Pharmaceuticals (UAB Research Park), have described a new mechanism of anti-tumour action, identified during the study and development of the new drug ABTL0812.
Experimental Combination Surprises with Anti-HIV Effectiveness
A compound developed to protect the nervous system from HIV surprised researchers by augmenting the effectiveness of an investigational antiretroviral drug beyond anything expected.
UTSW Researchers Identifies How Drugs Alter Pancreatic Cancer Cells
The findings were published in Cell Reports.
Researchers Identify Process that Causes Chronic Neonatal Lung Disease
Study determines how the NLRP3 inflammasome activates the protein Interleukin 1 beta.
Dengue Vaccine Enters Phase 3 Trial
Investigational vaccine to prevent ‘breakbone fever’ developed at NIH.
Trying to Conceive Soon After a Pregnancy Loss May Increase Chances of Live Birth
NIH study finds no reason for delaying pregnancy attempts after a loss without complications.
BRCA1 Deficiency Increases the Sensitivity of Ovarian Cancer Cells to Auranofin
An anti-rheumatic drug could improve the prognosis for ovarian cancer patients exhibiting a deficiency of the DNA repair protein BRCA1, a study suggests.
Shingles Vaccine Helps Protect Older Patients with End-stage Renal Disease
Kaiser Permanente study advances knowledge about safety and effectiveness of vaccine commonly given to older adults.
AMRI Acquires Whitehouse Laboratories
Strategically extends AMRI's analytical offerings in rapidly expanding area of outsourcing services.
Scroll Up
Scroll Down
SELECTBIO

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!