Mircera (methoxy polyethylene glycol-epoetin beta; Roche/Vifor/Chugai) is a novel erythropoiesis-stimulating agent (ESA) designated as a continuous erythropoietin receptor activator. The drug was originally available in Europe and Japan, and launched in the US in late 2015. It has the potential to overtake the current market leader Epogen (epoetin alfa; Amgen/Kyowa Hakko Kirin/Johnson & Johnson) in the anemia in chronic kidney disease market, on account of its superior dosing interval and cost efficiency. However, the drug still leaves significant unmet needs due to serious safety concerns. Clinical trials demonstrating these concerns have caused health agencies to issue strict guidelines regarding doses and use of ESAs, which have reduced ESA use and are likely to affect Mircera’s future uptake.
Mircera is administered by intravenous or subcutaneous injection, and targets the erythropoietin receptor, initiating the same pathway as native erythropoietin and triggering increased blood production in bone marrow.
TABLE OF CONTENTS
4 Product Profiles
4 Mircera : Anemia in chronic kidney disease
LIST OF FIGURES
12 Figure 1: Mircera for anemia in chronic kidney disease – SWOT analysis
13 Figure 2: Datamonitor Healthcare’s drug assessment summary of Mircera for anemia in chronic kidney disease
14 Figure 3: Datamonitor Healthcare’s drug assessment summary of Mircera for anemia in chronic kidney disease
16 Figure 4: Mircera sales for anemia in chronic kidney disease across the US, Japan, and five major EU markets, by country, 2015–24
LIST OF TABLES
4 Table 1: Mircera drug profile
6 Table 2: Mircera pivotal trial data in anemia in chronic kidney disease
11 Table 3: Mircera late-phase trial data in anemia in chronic kidney disease
17 Table 4: Mircera sales for anemia in chronic kidney disease across the US, Japan, and five major EU markets, by country ($m), 2015–24
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