In the United States a new drug for HIV with multidrug-resistant was approved

During the Conference on Retroviruses and Opportunistic Infections (CROI 2018) in Boston the US Food and Drug Administration (FDA) announced that it has approved ibalizumab-uiyk, to be marketed as Trogarzo, for people with HIV who have limited options due to extensive prior treatment experience and multidrug-resistant virus.

“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,” said Jeff Murray, M.D., deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “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. New treatment options may be able to improve their outcomes.”

As we reported before, Ibalizumab (previously known as TMB-355 and TNX-355) is an investigational humanized monoclonal antibody being developed TaiMed Biologics and licensed to Theratechnologies Inc for the treatment of multidrug resistant HIV-1 infection. Ibalizumab is manufactured by WuXi PharmaTech in China and USA.

Rather than attacking HIV directly, ibalizumab is an antibody that binds to the CD4 receptor on T-cells, where it blocks a shape change necessary for the virus to enter cells. It is administered by intravenous infusion every two weeks. Ibalizumab is the first biologic agent to be approved for HIV, the first antiretroviral that does not require daily dosing, and the first anti-HIV therapy with a novel mechanism to be introduced in a decade, Aidsmap reports.

Ibalizumab will be priced at US$118,000 annually – far exceeding the cost of existing HIV medications, but in line with biologics for cancer and other diseases.