Reliance GeneMedix pulls EU marketing application for Epostim

The European Medicines Agency (EMA) says it has been formally notified by UK-based Reliance GeneMedix (GMX: LN) of its decision to withdraw its application for a centralized marketing authorization for the medicine Epostim (erythropoietin), 2000IU/0.5ml, 4000IU/0.4ml, and 10 000IU/ml solution for injection in pre-filled syringes.

This medicine was intended to be used for the following indications:

* treatment of anemia associated with chronic renal failure in pediatric and adult patients on hemodialysis and adult patients on peritoneal dialysis;
* treatment of severe anemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis;
* treatment of anemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumors, malignant lymphoma or multiple myeloma;
* to increase the yield of autologous blood from patients in a predonation program; and
* to reduce exposure to allogenic blood transfusions in adult non-iron deficient patients prior to major elective orthopaedic surgery.

The marketing application for Epostim was submitted to the Agency on October 29, 2010. At the time of the withdrawal it was under review by the Agency's Committee for Medicinal Products for Human Use (CHMP).