Pharmacosmos A/S initiates studies of Monofer (isomaltoside 1000)for iron deficiency anaemia and non-dialysis dependent kidney disease to support FDA approval.

Pharmacosmos announced initiation of a novel study programme to obtain FDA approval of Monofer (isomaltoside 1000) . The study programme consists of two large-scale US trials in patients with iron deficiency anaemia (FERWONIDA) and non-dialysis dependent chronic kidney disease (FERWONNEPHRO) The trials will enroll 3,000 patients from more than 300 sites across the US, randomised into groups receiving either Monofer (iron isomaltoside) or Venofer (iron sucrose), the most widely used IV iron preparation in the world.

Pharmacosmos expects the trials to complement its recently completed studies in iron deficiency anaemia and chronic kidney failure, 'Provide' and 'Progress', which respectively demonstrated superiority on their primary efficacy endpoints over iron sucrose and oral iron. The studies will further supplement Pharmacosmos' landmark study (IRONMAN) recently initiated in collaboration with the British Heart Foundation in patients with chronic heart failure to demonstrate improvements in hard clinical endpoints such as cardiovascular mortality and hospitalisation for worsening heart failure with Monofer. Both US studies will be funded by Pharmacosmos and are expected to run over several years.

Comment:Monofer is an iron-carbohydrate complex for intravenous administration. Monofer is already marketed in more than 30 countries, primarily in Europe, for the treatment of iron deficiency and iron deficiency anaemia. Monofer is manufactured by Pharmacosmos, Denmark.