Gilenya is a synthetic derivative of ISP-1 (myriocin), a fungal metabolite of the Chinese herb isaria sinclarii which acts as a potent agonist at four of the S1P receptors (S1P1, S1P3, S1P4, and S1P5). This S1P agonist acts to reduce the overall number of circulating lymphocytes available to mount an autoimmune reaction to the myelin sheath surrounding axons in MS.
Gilenya is a once-daily oral capsule developed by Mitsubishi Tanabe Pharma. In 1997, Novartis obtained exclusive worldwide development rights, except in Japan, which remain with Mitsubishi. In June 2010, a US Food and Drug Administration advisory panel unanimously recommended Gilenya for use in relapsing-remitting MS patients, and it was approved at the end of September 2010 to become the first disease-modifying oral MS therapy in the US. Gilenya is now approved and available in the US, Japan, and the EU after launching in these regions during 2011.
LIST OF FIGURES 7 Figure 1: Gilenya for multiple sclerosis – SWOT analysis
8 Figure 2: Datamonitor Healthcare’s drug assessment summary for Gilenya in multiple sclerosis
9 Figure 3: Datamonitor Healthcare’s drug assessment summary for Gilenya in multiple sclerosis
11 Figure 4: Gilenya sales for multiple sclerosis across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES 5 Table 1: Gilenya drug profile
6 Table 2: Gilenya pivotal trial data in multiple sclerosis
12 Table 3: Gilenya sales for multiple sclerosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
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