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The agency has approved a new HIV treatment for patients with "limited treatment options".
On March 6, 2018, FDA approved Trogarzo (ibalizumab-uiyk), a new antiretroviral medication for adult patients living with multidrug-resistant (MDR) HIV who have tried multiple HIV medications in the past and whose HIV infections cannot be successfully treated with other available therapies.
Ibalizumab-uiyk, a humanized monoclonal antibody, is the result of a partnership between Theratechnologies, a Canadian pharmaceutical company focused on developing HIV treatments, and biotechnology company TaiMed Biologics. The drug is a CD4-directed, post-attachment HIV-1 inhibitor that binds to CD4+ receptors on host cells and blocks the HIV virus from infecting the cells while preserving normal immunological function, as stated by Theratechnologies.
“[The] approval of Trogarzo by [FDA] is great news for people infected with difficult-to-treat [MDR] HIV. We look forward to bringing this much-needed therapy to
patients in the [United States] within six weeks,” said Luc Tanguay, president and CEO at Theratechnologies, in a company press release.
The drug is intended to be used in combination with other antiretroviral medications and is administered intravenously once every 14 days by a trained medical professional. FDA granted this application fast track, priority review, and breakthrough therapy designations, in addition to orphan drug designation.
“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 [MDR] HIV, limiting their treatment options and putting them at a high risk of HIV-related complications and progression to death,” said Jeff Murray, MD, deputy director of the Division of Antiviral Products, FDA’s Center for Drug Evaluation and Research, in an agency press release. “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.”