CSL Vifor announced that the FDA granted its partner American Regent, Inc., a Daiichi Sankyo Group company, approval for Injectafer® for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III* to improve exercise capacity.
"We are very pleased that the FDA has approved the heart failure label extension of Injectafer®, and congratulate our partner on this milestone", said Hervé Gisserot, General Manager of CSL Vifor. "Every second patient with chronic heart failure suffers from iron deficiency, with a significant number of patients either not being diagnosed or inadequately treated for iron deficiency. We are confident that Injectafer® can make a meaningful contribution to achieve key therapeutic goals in the treatment of these patients."
The value of treating iron deficiency in heart failure patients has been clearly recognized by leading guideline committees such as the American Heart Association, the American College of Cardiology, the Heart Failure Society of America as well as the European Society of Cardiology.
The FDA approval was supported by CSL Vifor's randomized placebo-controlled study, CONFIRM-HF (NCT01453608), that evaluated the efficacy and safety of ferric carboxymaltose in adult patients with symptomatic heart failure and iron deficiency. The treatment over a 1-year period resulted in a significant and sustainable improvement in exercise capacity in this patient population.
CSL Vifor has granted American Regent, Inc., a Daiichi Sankyo Group company, an exclusive right to develop, manufacture and market Injectafer® in the United States. Please also visit https://americanregent.com/news/ to access the public announcement from American Regent, which does not form a part of this release.
*The New York Heart Association Functional Classification is used by Healthcare Professionals to classify patients' heart failure based on the severity of their symptoms. Patients who have a slight or marked limitation of their physical activity due to fatigue, palpitation and/or dyspnea are considered to have class II or class III heart failure, respectively.
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