Injectafer® approved in the U.S. for the treatment of iron deficiency in patients with heart failure

2023-06-05

上市批准AHA会议

Injectafer® (ferric carboxymaltose) is now the first and only intravenous (i.v.) iron replacement therapy in the U.S. indicated for improvement in exercise capacity in adult patients with symptomatic heart failure who have iron deficiency

ST. GALLEN, Switzerland, June 5, 2023 /PRNewswire/ -- CSL Vifor today announced that the U.S. Food and Drug Administration (FDA) has 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.1

"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.2

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.3

About

CSL Vifor

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).

The parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, www.cslvifor.com.

About Injectafer / Ferinject

Injectafer® / Ferinject® (ferric carboxymaltose) is an i.v. iron therapy with market authorization in 85 countries by May 2023. It has a track record of delivering significant value to patients and healthcare systems which is based on extensive clinical data and more than 25 million patient years of exposure. Injectafer is the most extensively studied IV iron.4,5

Injectafer is indicated for the treatment of iron deficiency in patients with heart failure; iron deficiency anemia (IDA) in adult and pediatric patients 1 year of age and older who have either intolerance to oral iron or an unsatisfactory response to oral iron; and adult patients with IDA who have non-dialysis dependent chronic kidney disease.1

References:

1 Injectafer [package insert]. Shirley, NY: American Regent, Inc.; May 2023.

2 Ponikowski P, van Veldhuisen DJ, Comin-Colet J, et al. Beneficial effects of long-term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency (CONFIRM-HF). Eur Heart J. 2015 Mar 14;36(11):657-68.

3 Classes of Heart Failure. American Heart Association. May 2017. https://www.heart.org/en/health-topics/heart-failure/what-is-heart-failure/classes-of-heart-failure

4 Data on file. Injectafer Studies. Daiichi Sankyo Inc., Basking Ridge, NJ.

5 CSL Vifor Press Release. https://www.viforpharma.com/ferinjectr-approved-china-treatment-iron-deficiency-adult-patients. Accessed May 2023.

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SOURCE Vifor International AG (CSL Vifor)