Swiss-based Vifor Pharma has initiated three clinical trials known as AFFIRM-AHF, FAIR-HF2 and HEART-FID, to assess the efficacy of Ferinject on morbidity and mortality outcomes in systolic heart failure and iron deficiency patients.

Ferinject is a non-dextran-based intravenous (IV) iron replacement therapy with ferric carboxymaltose as the active pharmaceutical ingredient.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The trials are designed to support the positive findings from the previous FAIR-HF, CONFIRM-HF and EFFECT-HF trials that demonstrated statistically significant benefits of Ferinject in relation to symptoms, functional capacity and oxygen consumption.

The AFFIRM-AHF trial is set to be conducted in 1,100 acute heart failure patients and will involve administration of Ferinject or placebo prior to the discharge of patients from hospital after an episode of acute heart failure.

The trial will monitor repeat hospitalisation rate and death as the primary endpoint.

“We are encouraged by the results of an analysis from the CONFIRM-HF trial, which showed a reduction in hospitalisation for worsening heart failure in patients with systolic chronic heart failure and iron deficiency who were treated with Ferinject.”

CONFIRM-HF and AFFIRM-AHF principle investigator professor Piotr Ponikowski said: “We are encouraged by the results of an analysis from the CONFIRM-HF trial, which showed a reduction in hospitalisation for worsening heart failure in patients with systolic chronic heart failure and iron deficiency who were treated with Ferinject.

“This gives us reason to believe we may also be able to have a positive impact on vulnerable acute heart failure patients with iron deficiency and the AFFIRM-AHF trial sets out to prospectively study this.”

Funded by Germany’s University Medical Centre Hamburg-Eppendorf (UKE), the FAIR-HF2 trial will evaluate Ferinject in 1,200 systolic CHF and iron deficiency subjects, with recurrent heart failure hospitalisation rate and cardiovascular death being the primary endpoint.

The HEART-FID trial is designed to investigate the effect of Ferinject on 12-month rate of death, hospitalisation for worsening heart failure and the six-month change in a six-minute walk for patients in heart failure with iron deficiency.

The trial will be conducted by the firm’s US partner American Regent in 3,000 adults across North America.