Mavenclad contains cladribine, a small molecule that suppresses the immune system by selectively targeting lymphocytes, which are cells that seem to be major players in MS pathological mechanisms. This purine nucleoside analog is in fact a prodrug; after being phosphorylated into its active form, cladribine incorporates into cellular DNA. This consequently inhibits protein production and DNA synthesis and repair, ultimately resulting in cell apoptosis.
In August 2017, Mavenclad was finally approved by the European Medicines Agency (EMA) for the treatment of highly active relapsing MS, after several years of unsuccessful attempts. Both the EMA and the US Food and Drug Administration (FDA) have rejected previous regulatory applications from Merck KGaA, dating back to 2009, leading the company to suspend further development. However, re-analyses of existing trials and long-term safety data from the PREMIERE registry allowed Merck KGaA to refile in the EU. There is no current timeline on a potential resubmission of Mavenclad with the FDA, although the company has stated its intention to do so.
TABLE OF CONTENTS
4 Product Profiles
LIST OF FIGURES 7 Figure 1: Mavenclad for multiple sclerosis – SWOT analysis
8 Figure 2: Datamonitor Healthcare’s drug assessment summary for Mavenclad in multiple sclerosis
9 Figure 3: Datamonitor Healthcare’s drug assessment summary for cladribine in multiple sclerosis
11 Figure 4: Mavenclad sales for multiple sclerosis across the US, Japan, and five major EU markets, by country, 2016–25
LIST OF TABLES 5 Table 1: Mavenclad drug profile
6 Table 2: Mavenclad pivotal trial data in multiple sclerosis
12 Table 3: Mavenclad sales for multiple sclerosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
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