In May 2006, Biogen acquired Fumapharm and its pipeline multiple sclerosis (MS) drug dimethyl fumarate, coining it first BG-12 and later Tecfidera. Although Tecfidera’s mechanism of action is not yet fully elucidated, it is thought to activate the nuclear factor (erythroid-derived 2)-like 2 transcriptional pathway, which studies have shown defends against oxidative stress-induced neuronal death, protects the blood-brain barrier, and supports maintenance of myelin integrity in the central nervous system. The prevention of immunoactivation of T cells is caused by the combination of cytoprotective and anti-inflammatory properties that Tecfidera displays.
Tecfidera was approved for the treatment of relapsing forms of MS in the US and for the treatment of relapsing-remitting MS in the EU in March 2013 and February 2014, respectively. The drug is also undergoing regulatory review in Japan.
LIST OF FIGURES 8 Figure 42: Datamonitor Healthcare’s drug assessment summary of ozanimod for multiple sclerosis
9 Figure 42: Ozanimod sales for multiple sclerosis across the US and five major EU markets, by country, 2016–25
12 Figure 42: Ponesimod for multiple sclerosis – SWOT analysis
LIST OF TABLES 5 Table 1: Tecfidera drug profile
6 Table 2: Tecfidera pivotal trial data in multiple sclerosis
10 Table 29: Plegridy sales for multiple sclerosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
13 Table 4: Tecfidera sales for multiple sclerosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
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