Business Wire

Full Results From AFFIRM-AHF Study Show Ferinject ® Significantly Reduces Hospitalizations After Acute Heart Failure in Patients With Iron Deficiency

Share

Regulatory News:

Vifor Pharma today presented the full results from the AFFIRM-AHF study at the 2020 American Heart Association (AHA) Scientific Sessions virtual congress. Simultaneously, results were published in the peer-reviewed medical journal The Lancet. The study evaluated the effect of Ferinject® (intravenous ferric carboxymaltose) on heart failure (HF) hospitalizations and cardiovascular (CV) mortality in iron deficient patients after hospital stabilization for acute heart failure (AHF).

The study demonstrated there were significantly fewer hospital readmissions due to HF among patients treated with Ferinject® compared to placebo. After 52 weeks, patients who received iron supplementation were 26% less likely to be re-admitted to the hospital for HF compared to placebo, after only one or two injections [RR 0.74; 95% CI 0.58-0.94; p=0.013].

“This is the first study demonstrating the benefits of iron supplementation initiated in stabilized patients hospitalized for AHF,” said Prof Piotr Ponikowski, Principle Investigatorand Head of the Department of Heart Diseases, Wroclaw Medical University in Wroclaw, Poland. “The study showed that administration of Ferinject® in stabilized AHF patients with iron deficiency significantly reduces the risk of subsequent HF hospitalizations, and highlights the need for AHF patients to be more frequently screened for iron deficiency.”

“We are delighted to have presented full data from the AFFIRM-AHF study at the American Heart Association Scientific Sessions congress. This important data strengthens the evidence previously generated in large studies such as FAIR-HF and CONFIRM-HF,” said Dr Klaus Henning Jensen, Chief Medical Officer Vifor Pharma. “Iron deficiency is a frequent, yet often unrecognized co-morbidity in heart failure, and this trial makes a significant contribution to the growing body of evidence showing the importance of detecting and managing iron deficiency in patients after heart failure.”

On September 24, 2020 Vifor Pharma announced that overall AFFIRM-AHF narrowly missed the conventional 5% statistical significance on the primary composite endpoint, but numerically reduced total CV death and HF re-hospitalization events by 21% [RR 0.79; 95% CI 0.62-1.01; p=0.059]. Ferinject® was well tolerated and without unexpected safety findings. No increase in mortality was seen and death from cardiovascular (CV) causes was similar between groups [RR 0.96; 95% CI 0.70-1.32].

The outbreak of the COVID-19 pandemic resulted in significant disruption to the healthcare systems, with a 40% reduction in HF hospitalizations in Europe between March and June 20202. HF patients are particularly at risk when suffering COVID-19. Therefore prior to study completion, COVID-19 sensitivity analysis was pre-specified which excluded subjects reporting from the date of the outbreak in each country. Adjusted for COVID-19 impact the composite endpoint was more robust and significant [RR 0.75; 95% CI 0.59-0.96; p=0.024].

Additional significant results were seen with several secondary outcomes, including treatment benefits with Ferinject® observed seen on the time to first HF hospitalization or CV death (p=0.030) and days lost due to HF hospitalizations and CV death (p=0.035). These effects were more pronounced in the pre-COVID-19 analyses.

AFFIRM-AHF is the first of three ongoing mortality and morbidity trials including FAIR-HF2 and HEART-FID to understand the full potential of Ferinject® for those suffering from heart failure and iron deficiency. The study was a randomized, double-blind placebo-controlled trial with 1,108 patients in 15 countries, designed to evaluate the effect of Ferinject® or placebo administered prior to and subsequent to discharge in patients after AHF and iron deficiency on recurrent HF hospitalizations and CV death at 52 weeks after randomization.

Iron deficiency is present in approximately 80% of patients after AHF and indicates poor prognosis. It is associated with poor quality of life and increased risk for hospitalization and mortality, regardless of the presence or absence of anemia. Hospitalization due to AHF represents a growing health care problem that is associated with a higher risk of adverse clinical outcomes and huge economic burden.

Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
For more information, please visit viforpharma.com

About AFFIRM-AHF
The AFFIRM-AHF study is a multi-centre, randomised, double-blind, placebo-controlled trial, comparing the effect of Intravenous Ferric Carboxymaltose (FCM) on hospitalizations and mortality in iron deficient patients admitted for Acute Heart Failure (AHF). AFFIRM-AHF is the first study that evaluates the benefit of Ferinject® on hospitalizations and mortality in a very high risk population with iron deficiency and admitted in hospital for an episode of acute heart failure.


1 Left ventricular ejection fraction (LVEF)
2 Sokolski M, Gajewski P, Zymlinski R, et al. Impact of coronavirus disease 2019 (COVID-19) outbreak on acute admissions at the emergency and cardiology departments across Europe. Am J Med. 2020 Sep 30:S0002-9343(20)30825-1. doi:10.1016/j.amjmed.2020.08.043. Epub ahead of print. PMID: 33010226; PMCID: PMC7526639.

Contact information

Contact and further information:

Media Relations
Nathalie Ponnier
Global Head Corporate Communications
+41 79 957 96 73
media@viforpharma.com

Investor Relations
Julien Vignot
Head of Investor Relations
+41 58 851 66 90
investors@viforpharma.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Disruptive Tech Asean Comments That Semiconductor Industry in China Eyes on a New Beyond the Manufacturing Of 7nm Chips3.12.2020 11:00:00 CETPress release

Disruptive Tech Asean learnt from Li Ke from China Semiconductor Industry Association (CSIA) that an integrated circuit industry is vital for developing modern industries, and China is therefore imperative to localize chip industry supply chain and develop homegrown-core chips. Li Ke believes that China will have the ability to fully mass-produce its own 28nm chips in one or two years, as well as having a completely domestic industry chain and independent chip manufacturing capabilities. According to Gartner’s forecast at the end of 2019, the global semiconductor market would grow by 12.5% in 2020. Yet, with devastating impacts of the COVID-19 pandemic, the forecast was revised to a decline of 0.9%. According to Andrew Norwood, Research Vice President at Gartner, “COVID-19 has distorted supply chain and manufacturing operations across the world and will lead to a drastic drop in consumer and enterprise spending across most areas with a few exceptions.” The US-China trade war has also c

LivaNova and Gyrus Capital Enter into Agreement for the Purchase of Heart Valve Business3.12.2020 11:00:00 CETPress release

LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, and Gyrus Capital (Gyrus), an investment firm dedicated to investments in the healthcare and sustainability sectors, today announced they have entered into an agreement whereby entities funded and controlled by Gyrus will acquire the LivaNova heart valve (HV) business. The LivaNova Board of Directors unanimously approved the divestiture, which it believes will enable the Company to sharpen its focus within its primary platforms, neuromodulation and cardiovascular, and to dedicate increased resources toward executing its promising pipeline opportunities. Once the transaction is complete, Gyrus intends to focus management attention and investment on the HV business to position it to become a leading player in the surgical heart valve market globally, translating into even greater opportunities for employees, customers and patients. This press release features multimedia. View the full release here: ht

Telefonica UK (O2) and IDEMIA Working to Securely Connect 23 Million Homes in the UK With Smart Meters By 20253.12.2020 10:30:00 CETPress release

O2 in partnership with IDEMIA, the global leader in Augmented Identity, has today supplied secure connectivity to over 4 million UK homes with a second generation Smart Meter. The rollout will continue into the future, supporting the UK government program to deploy Smart Meters for all UK households and small businesses. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201203005370/en/ (Photo: Business Wire) As part of the transition to a flexible energy market that requires a low carbon economy and sustainable consumption habits, smart meters give consumers near real-time information on energy helping them to take control of their energy usage and bring an end to estimated billing. Smart meters come with in-home displays to enable consumers to have a better understanding of their energy usage. Against that backdrop, customers using the latest generation of smart meters are reporting an average saving of around 10% per month.

Measuring What Matters: A New Approach to Assessing Sovereign Climate Risk3.12.2020 09:23:00 CETPress release

Moody’s affiliate Four Twenty Seven today released a report analyzing the future exposure of the global population, the economy, and agriculture to a range of climate hazards, exploring both global trends and findings by country. Leveraging new analytics developed by Four Twenty Seven, the report assesses exposure to floods, heat stress, hurricanes and typhoons, rising sea levels, wildfires, and water stress and is based on the only known global dataset matching physical climate risk exposure to population location, GDP Purchasing Power Parity (PPP), and agricultural areas within countries. “This novel dataset provides a detailed view of the exposure of key human and economic assets around the world. Understanding exposure is critical for investors and credit institutions to price climate risk, but also to help direct finance flows towards adaptation and resilience where they’re most needed,” says Emilie Mazzacurati, Global Head of Moody’s Climate Solutions in Moody’s ESG Solutions Gro

PMI Commits to Disability Inclusion by Joining The Valuable 5003.12.2020 09:05:00 CETPress release

Philip Morris International Inc.(PMI) (NYSE: PM) today announced that CEO André Calantzopoulos has joined The Valuable 500—a global movement putting disability inclusion on the business leadership agenda. Signing on to this initiative marks another significant step in PMI’s journey of advancing inclusion and diversity in the workplace. André Calantzopoulos said: “Businesses with a global operating footprint, such as PMI, can make a meaningful impact by ensuring that everyone—including individuals with a disability—can prosper in the workplace. By signing The Valuable 500, I am proud to join forces with a host of other CEOs who are challenging their organizations and the business world to broaden the focus of their inclusion and diversity efforts, and to help create a more inclusive world for the 1.3 billion people with disabilities. This is the right thing to do as part of our broader work to create a more equitable society. And it is also the smart thing to do, allowing PMI to tap int

Siemens Smart Infrastructure Chooses AWS as Its Preferred Cloud Provider for SAP Environments3.12.2020 09:01:00 CETPress release

Today, Amazon Web Services (AWS), an Amazon.com company (NASDAQ: AMZN), announced that Siemens Smart Infrastructure, a business of the Siemens AG group focusing on energy distribution and intelligent buildings, is moving its SAP infrastructure to AWS. The business will migrate over 20 Enterprise Resource Planning (ERP) and Supply Chain Management (SCM) systems,based on SAP HANA, to AWS before the end of 2021. These systems support business-critical processes in areas such as manufacturing, operations, and sales across different business units including Building Products, Electrical Products, Digital Grid, and Distribution Systems. Moving these workloads to AWS will enable Siemens Smart Infrastructure to significantly shorten hardware refresh cycles, increase agility to test and deploy new systems, and provide the foundation for the company’s future transformation using SAP S/4HANA technology. This is the first migration of production-scale SAP systems to the cloud across the Siemens AG

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom