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Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 26 Jun 2012 - 11:00 PDT
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Ferumoxytol, a new intravenous (IV) iron therapy to treat iron deficiency anemia (IDA) in adults with chronic kidney disease (CKD) has received marketing authorization by the European Commission (EC), according to Takeda Pharmaceutical Company Limited and AMAG Pharmaceuticals Inc.
The marketing authorization, which is valid in the current EU Member States, as well as in IceLand and Norway, will be held by Takeda Global Research Development Centre (Europe) Ltd.
Trevor Smith, Head of Commercial Operations, Europe Canada, Takeda Pharmaceuticals, explained:
"The granting of European marketing authorization for ferumoxytol marks an important milestone for Takeda in our ongoing commitment to the field of renal medicine. We look forward to providing ferumoxytol, a valuable new therapeutic option, to clinicians in the near future."
The authorization is based on data from three pivotal Phase III safety and efficacy studies.
In the studies, ferumoxytol was administered as a rapid injection to 1,726 participants, including 1,562 participants with all stages of CKD. Across the spectrum of CKD, researchers found that ferumoxytol increased hemoglobin levels significantly more than oral iron supplements.
In addition, the researchers found that ferumoxytol was well tolerated by study participants with CKD and IDA and had similar a overall treatment-related adverse event rate to oral iron.
Furthermore, retrospective observational data from three large hemodialysis clinics in the United States further supported these outcomes. The clinics administered over 33,300 doses of ferumoxytol and involved more than 8,600 patients.
Anemia is often caused by iron deficiency and usually observed in the later stages of chronic kidney disease, as renal function deteriorates and production of red blood cells declines. Iron deficiency anemia can significantly affect patients' lives, causing shortness of breath, fatigue. In addition, IDA can increase the risk of developing cardiovascular complications, such as congestive heart failure.
Francesco Locatelli, Scientific Director, Division of Nephrology and Dialysis, Alessandro Manzoni Hospital, Lecco, Italy, explained:
"While treatments for iron deficiency anemia have been widely available for many years, the disease continues to place a significant burden on the everyday life of CKD patients worldwide, and its management should be tailored to appropriately address the clinical consequences of this debilitating condition.Ferumoxytol offers an effective and convenient alternative to current therapies in the management of anemia, and news of its approval will be warmly received by the renal community."
Written by Grace Rattue
Copyright: Medical News Today
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