CHMP recommends approval of Trogarzo for multidrring-resistant TREATMENT of HIV-1

recently, taiwan
's TaiMed partner, Canadian pharmaceutical company
Theratechnologies, announced that the European Medicines
Authority (EMA) Human Medicines
Committee (CHMP) has issued an active review recommending approval of Trogarzo (ibalizumab) for multidrring-resistant HIV-1 treatment.In the United States, F
DA
approved Trogarzo (ibalizumab-uiyk) in March 2018 for adult HIV-1 infections that have previously received multiple HIV drugs
and whose HIV infection is resistant to currently available therapies.
Previously, the FDA had granted Trogarzo breakthrough drug eligibility, orphan drug eligibility, fast-track eligibility, and priority review eligibility.
About TrogarzoTrogarzo represents the first HIV treatment drug in more than a decade with a new mechanism of action, developed by Zhongyuxin to treat multidrrroid resistance to HIV-1 infection.
Trogarzo is the first approved single anti-drug in the field of HIV treatment, and the first long-acting new drug for HIV, unlike other antiretroviral drugs, which are mainly combined with the second extracellular domain of CD4-T cellular mediators, far from the MHC II molecular binding site, which can potentially prevent HIV from infecting CD4-plus immune cells while retaining normal immune function.
Trogarzo's HIV-1 resistance to all approved antiretroviral drugs is effective.
Trogarzo is an intravenous drip of humanized IgG4 monoantigen, a single load dose of 2000 mg after every 2 weeks after infusion of 800 mg, the drug targets the second extracellular domain combined with CD4-T cellular mediators to prevent HIV from invading these cells, the drug is similar to PRO140 is a "viral invasion inhibitor", but different from the market has been approved drug other binding points.
Trogarzo's approval in the United States is based on data from a single-group, multi-center Phase III clinical study (TMB-301, NCT02475629). The study included 40 patients with multidring-resistant HIV-1 who had received multiple treatments, and data showed that in the 25th week of treatment, 43% of patients achieved viral suppression (viral load <50), 55% and 48% reduced viral load ≥1log10 and ≥2log10). (Drug Information Network)