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Galenica to commercialize Roche’s Mircera in US and Puerto Rico

Serbian pharmaceutical firm Galenica has entered into an exclusive license agreement for the commercialization of Swiss drug-maker Roche’s prescription medicine Mircera (methoxy polyethylene glycol-epoetin beta) in the US and Puerto Rico.

Mircera is used to treat symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients.

The company said that the drug represents a complement to its existing product portfolio for patients with CKD and iron deficiency.

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved Mircera for the treatment of anaemia associated with CKD in adult patients on dialysis as well as those not on dialysis.

Anaemia associated with CKD will leads to reduced quality of life and increased cardiovascular disease, hospitalizations, cognitive impairment and mortality.

Mircera is a long acting Erythropoietin Stimulating Agent (ESA) for bi-weekly or monthly treatment and it works like the human protein called erythropoietin to help the body make more red blood cells.

The drug is used to reduce or avoid the need for red blood cell transfusion.