CHMP recommends approval of Trogarzo (ibalizumab) for multidrug-resistant HIV-1 treatment

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(http://product(http:// The Committee (CHMP) has issued an active review recommending approval of Trogarzo (ibalizumab) for multidrug-resistant HIV-1 treatment 　　In the U.S., FDA (http:// approved Trogarzo (ibalizumab-uiyk) in March 2018 for HIV-1 adults who have previously received a variety of HIV drug (http:// and whose HIV infection is resistant to currently available therapies 　　Previously, the FDA has granted Trogarzo breakthrough drug eligibility, orphan drug eligibility, fast-track eligibility, and priority review eligibility 　　About Trogarzo
Trogarzo represents the first HIV treatment drug with a new mechanism in more than a decade, developed by Zhongyu New Drug to treat multidrug-resistant HIV-1 infections 　　Trogarzo is the first approved monoantigen in the field of HIV treatment, and the first long-acting new drug for HIV, unlike other antiretroviral drugs, the drug is mainly bound to the cd4-T cell receptor's secondary extracellular domain, away from the MHC II molecular binding site, can potentially prevent HIV infection CD4-immune cells, while retaining normal immune function 　　Trogarzo is effective in producing drug-resistant HIV-1 for all approved antiretroviral drugs 　　Trogarzo is a humanized IgG4 monoantigen with intravenous drips, with a single load dose of 2000mg and an injection of 800mg every 2 weeks, the drug targets the second extracellular domain bound to cd4-T cell receptors to prevent HIV from invading these cells, similar to PRO140, which is a "viral invasion inhibitor" but different from other approved drug binding sites 　　Trogarzo's approval in the United States is based on data from a single-group, multicenter Phase III clinical study (TMB-301, NCT02475629) The study enrolled 40 cases of multidrug-resistant HIV-1 infections that had been treated multiple times, and the data showed that in the 25th week of treatment, 43% of patients achieved virological inhibition (viral load 50), 55% and 48% of patients with reduced viral loads of 1log10 and 2log10