Lemtrada contains the monoclonal antibody alemtuzumab, which specifically targets cluster of differentiation (CD)52 expressed on the surface of normal and malignant T cells, thus depleting the T lymphocytes involved in the degradation of the myelin sheath.
In 2009, Genzyme acquired worldwide rights to alemtuzumab from Bayer, giving Genzyme primary responsibility for development and commercialization while Bayer would continue to fund development up until regulatory approval. In February 2011, Sanofi agreed to purchase Genzyme, with Genzyme becoming a wholly owned subsidiary.
Alemtuzumab was first approved in the US (as Campath) and EU as a first-line agent for the treatment of B-cell chronic lymphocytic leukemia, although Sanofi withdrew Campath from the market ahead of Lemtrada’s launch in MS in order to preserve its pricing structure.
Lemtrada was first approved for the treatment of relapsing-remitting MS in the EU in September 2013. The US Food and Drug Administration approved Lemtrada on its second regulatory cycle in November 2014, after first issuing a complete response letter in December 2013.
LIST OF FIGURES
9 Figure 44: Datamonitor Healthcare’s drug assessment summary of ozanimod for multiple sclerosis
10 Figure 22: Datamonitor Healthcare’s drug assessment summary for Ocrevus in multiple sclerosis
12 Figure 23: Datamonitor Healthcare’s drug assessment summary for Ocrevus in multiple sclerosis
LIST OF TABLES
5 Table 1: Lemtrada drug profile
6 Table 2: Lemtrada pivotal trial data in multiple sclerosis
13 Table 3: Lemtrada sales for multiple sclerosis across the US, Japan, and five major EU markets, by country ($m), 2016–25
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