Trogarzo (ibalizumab; Theratechnologies/TaiMed Biologics) is a recombinant humanized monoclonal antibody approved for the treatment of HIV-1 infection. It targets the HIV-1 post-attachment process by binding one of the domains of the CD-4 protein, which inhibits a conformational change in CD-4 that is necessary to allow entry of HIV into T-cells.
Trogarzo is the first monoclonal antibody to be approved for the treatment of HIV. Due to fulfilling an unmet need for additional treatments in the small niche of multidrug-resistant patients, Trogarzo has been priced at a significant premium to other therapies, at an annual list price of $118,000 in the US. While Trogarzo possesses a first-to-market advantage and is currently benefiting from a monopoly in multidrug-resistant patients, its inconvenient biweekly intravenous formulation is a key weakness which leronlimab (CytoDyn) (weekly subcutaneous) and fostemsavir (ViiV Healthcare) (oral twice daily) are aiming to exploit. TaiMed Biologics ultimately intends to develop a subcutaneous version of Trogarzo, but this will not be available before the aforementioned competitors’ anticipated US approvals begin to erode its market share. Nevertheless, during the short-lived monopoly period, Datamonitor Healthcare expects Trogarzo will generate substantial sales in the small salvage setting due to its premium price.
4 Drug Overview
5 Product Profiles
5 Trogarzo : HIV
LIST OF FIGURES
9 Figure 1: Datamonitor Healthcare’s drug assessment summary of Trogarzo for HIV
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of Trogarzo for HIV
12 Figure 3: Trogarzo sales for HIV across the US and five major EU markets, by country, 2018–27
LIST OF TABLES
5 Table 1: Trogarzo drug profile
6 Table 2: Approval history of Trogarzo for HIV in the US
7 Table 3: Late-phase trials of Trogarzo for HIV
8 Table 4: Trogarzo for HIV – SWOT analysis
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