The recent first global approval of Ibalizumab has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs, based on the development milestones tracked in AdisInsight.
Ibalizumab (Trogarzo™) developed by TaiMed Biologics received its first global approval in March 2018 in the US for the treatment of heavily treatment-experienced patients with multidrug resistant HIV-1 infection in combination with other antiretroviral medicines.
Ibalizumab, a humanised IgG4 monoclonal antibody, blocks HIV entry into CD4 cells without impairing normal immunological function. It is dispensed as an intravenous formulation that is given once every 2 weeks by a trained medical professional.
Although the annual rate of new HIV diagnoses in the US is trending down, the disease still impacts a large number of people globally. According to UNAIDS, almost 21 million people globally were accessing antiretroviral therapy in June 2017. In 2016, ~37 million people were living with HIV, and a further ~1.8 million became newly infected.
Ibalizumab was granted Breakthrough Therapy and Orphan Drug designations by the FDA, as well as processing the application via Fast Track and Priority Review.  The drug is the first CD4-directed post-attachment HIV-1 inhibitor and the first humanised monoclonal antibody for the treatment of HIV/AIDS.
“Trogarzo is the first drug in a new class of antiretroviral medications that can provide significant benefit to patients who have run out of HIV treatment options”, said Jeff Murray, M.D., deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “While most patients living with HIV can be successfully treated using a combination of two or more antiretroviral drugs, a small percentage of patients who have taken many HIV drugs in the past have multidrug resistant HIV, limiting their treatment options and putting them at a high risk of HIV-related complications and progression to death,” he further explained. 
Ibalizumab has no contraindications, but carries a warning regarding the observation of Immune Reconstruction Inflammatory Syndrome in patients receiving combination antiretroviral therapies.
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