Ferinject® granted upgraded recommendations in 2023 ESC heart failure guidelines

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The 2023 European Society of Cardiology (ESC) guidelines for acute and chronic heart failure (HF) include upgraded recommendations for intravenous (IV) iron supplementation, including Ferinject^® (ferric carboxymaltose), for the management of iron deficiency in patients with HF.

Phase IV HEART-FID study results and ferric carboxymaltose meta-analysis also presented at 2023 ESC Congress

ST. GALLEN, Switzerland, Aug. 28, 2023 /PRNewswire/ -- CSL Vifor is pleased to announce that the European Society of Cardiology (ESC) have upgraded recommendations in the ESC 2023 guidelines for the treatment of iron deficiency acute and chronic HF with IV iron supplementation, including Ferinject^®.

The guidelines include higher level of recommendations and address a broader patient group for the management of iron deficiency in HF patients with compromised heart function (HFrEF and HFmrEF).

• Intravenous iron supplementation is recommended in symptomatic patients with HFrEF and HFmrEF, and iron deficiency, to alleviate HF symptoms and improve quality of life. (Class I, level A)
• Intravenous iron supplementation with ferric carboxymaltose or ferric derisomaltose should be considered in symptomatic patients with HFrEF and HFmrEF, and iron deficiency, to reduce the risk of HF hospitalization, irrespective of hospitalisation history (Class IIa, level A).

"We are pleased that ESC's new heart failure guidelines have been updated to reflect the latest scientific evidence," said Fabio Dorigotti, Head of Global Medical Affairs at CSL Vifor. "Improving iron deficiency diagnosis followed by IV iron supplementation based on the updated guidelines means more patients may potentially benefit from IV iron treatment. We are particularly pleased with the updated recommendations for IV iron including Ferinject^® in the new 2023 focused update of the 2021 treatment guidelines. This revision will enable cardiologists and physicians to better treat more of the symptomatic heart failure patients with iron deficiency."

In addition, findings from the phase IV HEART-FID trial (NCT03037931) of ferric carboxymaltose were presented at the ESC congress 2023 in Amsterdam, Netherlands, and simultaneously published in the peer-reviewed medical journal New England Journal of Medicine.¹ HEART-FID is the largest and longest duration trial to date evaluating IV iron in HF patients with reduced ejection fraction and iron deficiency.

The trial approached but did not meet the pre-specified statistical significance of p<0.01 on the primary endpoint, which was a hierarchical composite of death and HF hospitalization at 12 months and change from baseline to 6 months in the 6-minute walk test distance (6-MWD). The results showed that with ferric carboxymaltose, there were numerically fewer deaths and hospitalizations for HF through 12 months and a modest benefit in the 6-MWD at 6 months compared to placebo. Ferric carboxymaltose was generally well tolerated and without unexpected safety findings.

"While the results from the HEART-FID study did not meet statistical significance at the pre-specified level, the totality of evidence with ferric carboxymaltose from prior studies assessing symptomatic and functional status endpoints – combined with recent clinical outcomes studies – show overall safety and potential benefits," said Robert Mentz, MD, Chief of the Heart Failure Section at Duke University Medical Center, Durham, US, and Clinical Lead for the trial.

To understand these new results in light of the totality of the evidence for IV iron in HF patients with iron deficiency, investigators also executed a pooled analysis using individual participant data from the three long-term trials FAIR-HF, CONFIRM-HF and HEART-FID of ferric carboxymaltose with a total of 4'501 patients.  It represents the largest analysis to date to examine the effects of ferric carboxymaltose on clinical outcomes and was presented at the ESC congress 2023 with a parallel acceptance of the manuscript in the peer-reviewed European Heart Journal.²

Treatment with ferric carboxymaltose in iron-deficient HF patients with reduced or mildly reduced left ventricular ejection fraction was associated with a reduction in the composite endpoint of total cardiovascular hospitalizations and cardiovascular death compared with placebo, and with significantly reduced risks of hospitalization due to heart failure or cardiovascular causes, with no effect on survival. 

"One in two patients with chronic HF has iron deficiency, with a significant number of patients not being diagnosed or inadequately treated for iron deficiency," commented Steve Pascoe, MD, Senior Vice President, Clinical and Therapeutic Area Strategy, CSL. "We are confident that the outcomes of this trial and the pooled analysis of ferric carboxymaltose are an important contribution to the growing body of evidence showcasing the advantages of IV iron treatment for HF patients."

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 the ESC guidelines

The ESC HF guidelines aim to provide practical, evidence-based recommendations for the diagnosis and treatment of HF, thereby improving and harmonizing standards of diagnosis and treatment of cardiovascular diseases for physicians, and potentially optimizing patient care. The ESC HF guidelines are updated periodically, with the 2023 version updated at the ESC congress end of August 2023.

About HEART-FID

HEART-FID is the first randomized clinical trial powered to evaluate the effects of intravenous ferric carboxymaltose on a hierarchical endpoint of death, heart failure hospitalizations, and functional status for adult patients with iron deficiency. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 3,065 patients at 281 international centers. Eligible patients were at least 18 years old in stable chronic heart failure with New York Heart Association functional class II to IV symptoms, ejection fraction ≤40%, iron deficiency (ferritin <100 ng/mL or ferritin 100–300 ng/mL with a transferrin saturation <20%), and documented heart failure hospitalization or elevated N-terminal pro-brain natriuretic peptide. The primary endpoint of the study was a hierarchical composite of death and heart failure hospitalization at 12 months and change from baseline to 6 months in the 6-minute walk test distance.

About the meta-analysis

The meta-analysis Impact of ferric carboxymaltose on heart failure-related clinical outcomes in patients with heart failure and iron deficiency: an individual participant data meta-analysis represents the largest pooled analysis to examine the effects of ferric carboxymaltose on clinical outcomes (hospitalizations and mortality) and the first to include the results of the HEART-FID trial. Patient-level data from the three randomized, placebo-controlled ferric carboxymaltose trials CONFIRM-HF, AFFIRM-AHF and HEART-FID with a total of 4'501 adults with HF and iron deficiency with ≥52 weeks follow-up were analysed. The co-primary efficacy endpoints were composite of total/recurrent cardiovascular hospitalizations and cardiovascular death and composite of total HF hospitalizations and cardiovascular death. Both endpoints were examined through 52 weeks of follow-up and based on events adjudicated independently by blinded events committees. Key secondary endpoints included individual components of the composite endpoints.

About Ferinject^®

Ferinject^® (ferric carboxymaltose) is an IV iron therapy with market authorization in 86 countries by August 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. Ferinject^® is the most extensively studied IV iron.³

References:

¹ Mentz RJ, Garg J, Rockhold FW, Butler J, De Pasquale CG, Ezekowitz JA, et al. Ferric carboxymaltose in heart failure with iron deficiency. N Engl J Med 2023 [published on-line] DOI: 10.1056/NEJMoa2304968.
² Ponikowski P, Mentz RJ, Hernandez AF, Butler J, Khan MZ, van Veldhuisen DJ, et al. Efficacy of Ferric carboxymaltose in heart failure with iron deficiency: an individual patient data meta-analysis. Eur Heart J 2023 [published on-line] DOI: 10.1093/eurheartj/ehad586.
³ Data on file. Injectafer Studies. Daiichi Sankyo Inc., Basking Ridge, NJ.

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