Pharmacosmos A/S announces publication of positive results from the FERWON-NEPHRO study

Pharmacosmos A/S announces publication of positive results from the FERWON-NEPHRO study and the pre-specified pooled safety analyses of the FERWON-NEPHRO and FERWON-IDA studies at the 56th ERA-EDTA congress in Budapest, Hungary.

FERWON-NEPHRO is the second trial in the FERWON study programme comprising two randomized, open-label, comparative, multi-centre trials including over 3000 patients in the US; FERWON-IDA included patients with iron deficiency anaemia of mixed origin and FERWON-NEPHRO included patients with iron deficiency anaemia and non-dialysis-dependent chronic kidney disease (NDD-CKD).

In the FERWON-NEPHRO study patients were randomized 2:1 to either Monofer® / Monoferric®  administered at baseline as a single dose of 1000 mg infused over 20 min or iron sucrose administered as 200 mg intravenous injections according to label and repeated up to 5 times. The co-primary endpoints were serious or severe hypersensitivity reactions and change in haemoglobin (Hb) from baseline to week 8. An additional key safety endpoint included the incidence of composite cardiovascular adverse events (AEs). Hypersensitivity reactions and cardiovascular AEs were adjudicated and confirmed by an independent and blinded adjudication committee.

Both primary endpoints in the FERWON-NEPHRO study were met. The frequency of patients reporting adjudicated serious or severe hypersensitivity reactions was 0.3% in the Monofer® / Monoferric® group and 0% in the iron sucrose group, and there was no statistically significant difference between the two treatment arms. Monofer® / Monoferric® demonstrated non-inferiority in Hb change from baseline to week 8 compared to iron sucrose, and led to a significantly more rapid and increased Hb response in the first 4 weeks. This was reflected in both Hb change from baseline and the proportion of patients with Hb increases ≥1 g/dL. Furthermore, the incidence of patients with blindly adjudicated composite cardiovascular AEs was statistically significantly lower with Monofer® / Monoferric®  compared to iron sucrose (4.1% vs 6.9%, p=0.025). The pre-specified pooled safety analyses of the FERWON-NEPHRO and FERWON-IDA studies also concluded that Monofer® / Monoferric®  was non-inferior to iron sucrose with respect to serious and severe hypersensitivity reactions (0.3% vs 0.2%). Monofer® / Monoferric® showed significantly lower incidence of cardiovascular events than iron sucrose in the pooled analysis (2.5% vs 4.1%, p=0.018). In both studies neither preparation induced severe hypophosphatemia (s-phosphate <1 mg/dL [<0.32 mmol/L]).

Lars Lykke Thomsen, Chief Medical Officer at Pharmacosmos, said: “The data from this large FERWON study programme is very robust, and confirms that a single administration of Monofer® / Monoferric® is efficacious with a good safety profile.”

Sunil Bhandari MD, lead author on the FERWON trial abstract, commented: “Intravenous administration of high-dose iron is the most efficient approach to treat iron deficiency anaemia in patients with NDD-CKD, and these results show that iron isomaltoside can provide that benefit; safely and effectively in a single dose. The lower incidence of cardiovascular events with iron isomaltoside treatment is an interesting finding, which provides reassurance for the use of iron isomaltoside when intravenous iron is indicated for patients with an increased risk of cardiovascular disease.”

About Monofer® / Monoferric®
Monofer® /Monoferric® (iron isomaltoside) is an iron-carbohydrate complex for intravenous administration. Monofer® / Monoferric® is marketed in more than 30 countries worldwide for the treatment of iron deficiency and iron deficiency anaemia. Monofer® / Monoferric® is manufactured by Pharmacosmos A/S, Denmark.

About iron deficiency anaemia
Iron deficiency anaemia (IDA) is a debilitating condition that affects almost 1 billion people worldwide. IDA is often associated with many chronic disorders such as renal diseases (including chronic kidney disease), cancers (including chemotherapy-induced anaemia), gynaecologic disorders (including abnormal uterine bleeding), and inflammatory bowel disease.

About Pharmacosmos A/S
Pharmacosmos A/S is a family-owned Danish pharmaceutical company headquartered in Holbæk, Denmark. The company was founded in 1965 and today sells its products in the UK, Scandinavia, and Germany through its own subsidiaries and across the world through partners. Pharmacosmos is a global leader in the development and marketing of medicines for the treatment of iron deficiency and iron deficiency anaemia. With a strong and ongoing commitment to R&D, Pharmacosmos is able to leverage a unique carbohydrate production platform along with an unrivalled expertise in the synthesis of iron-carbohydrate complexes to bring better treatments for patients suffering from iron deficiency. The state-of-the-art facilities in Denmark are approved by both the Danish Medicines Agency and the US Food & Drug Administration.