Xadago (safinamide; Newron Pharmaceuticals/US WorldMeds/Zambon/Meiji Seika Pharma) has a novel dual mechanism of action, based on the enhancement of the dopaminergic function through the reversible inhibition of monoamine oxidase B (MAO-B) and inhibition of excessive glutamate release by blocking the activity of the voltage-dependent sodium channels. Although Xadago was originally developed by Newron across the spectrum of Parkinson’s disease, it is approved only for mid-late stage Parkinson’s disease patients receiving levodopa and experiencing motor fluctuations. Its first approval came in the EU in February 2015, with a subsequent expansion to the US in March 2017.
Newron has sought out several commercial partners for Xadago, including out-licensing global rights to Zambon and Asian territory rights to Meiji Seika. Zambon has subsequently partnered with US WorldMeds for the drug’s commercialization in the US, while Eisai has obtained exclusive rights to Xadago in Japan.
LIST OF FIGURES
8 Figure 1: Xadago for Parkinson’s disease – SWOT analysis
9 Figure 2: Datamonitor Healthcare’s drug assessment summary of Xadago for Parkinson’s disease
10 Figure 3: Datamonitor Healthcare’s drug assessment summary of Xadago for Parkinson’s disease
12 Figure 4: Xadago sales for Parkinson’s disease across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES
6 Table 1: Xadago drug profile
7 Table 2: Xadago pivotal trial data in Parkinson’s disease
13 Table 3: Xadago sales for Parkinson’s disease across the US, Japan, and five major EU markets, by country ($m), 2016–25
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