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The Food and Drug Administration Feb. 6 approved ibalizumab-uiyk (Trogarzo) to treat multidrug-resistant HIV (MDR HIV) in adults, the agency announced.
“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,” Jeff Murray, MD, deputy director of the FDA Division of Antiviral Products, said in a statement. “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.”
Ibalizumab-uiyk, an HIV-1 inhibitor, was approved based on the results of a phase 3, single-arm study of 40 patients with MDR-HIV-1 who had high virus levels in their blood despite antiretroviral treatment. To be included in the study, all patients had to have received highly active antiretroviral therapy for at least 6 months prior. Over 24 weeks, patients were monitored to compare previous, infective treatments with ibalizumab-uiyk in conjunction with an optimized background regimen of antiretroviral drugs.
The majority of patients showed a significant decrease in their HIV-RNA levels 1 week after ibalizumab-uiyk was added to their previous drug regimens. After 24 weeks of treatment with ibalizumab-uiyk, in conjunction with other antiretroviral drugs, 43% of patients achieved HIV RNA suppression.
Ibalizumab-uiyk was granted Fast Track, Priority Review, and Breakthrough Therapy designations from the FDA. In addition, it was granted Orphan Drug designation, a program that encourages the development of drugs to treat rare diseases.
Ibalizumab-uiyk is administered once every 14 days in conjunction with other retroviral medications.
The most common adverse reactions to ibalizumab-uiyk were diarrhea, dizziness, nausea, and rash. Less common, and more severe, reactions were changes in the immune system.
Ibalizumab-uiyk will be marketed by Taimed Biologics USA.
The Food and Drug Administration Feb. 6 approved ibalizumab-uiyk (Trogarzo) to treat multidrug-resistant HIV (MDR HIV) in adults, the agency announced.
“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,” Jeff Murray, MD, deputy director of the FDA Division of Antiviral Products, said in a statement. “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.”
Ibalizumab-uiyk, an HIV-1 inhibitor, was approved based on the results of a phase 3, single-arm study of 40 patients with MDR-HIV-1 who had high virus levels in their blood despite antiretroviral treatment. To be included in the study, all patients had to have received highly active antiretroviral therapy for at least 6 months prior. Over 24 weeks, patients were monitored to compare previous, infective treatments with ibalizumab-uiyk in conjunction with an optimized background regimen of antiretroviral drugs.
The majority of patients showed a significant decrease in their HIV-RNA levels 1 week after ibalizumab-uiyk was added to their previous drug regimens. After 24 weeks of treatment with ibalizumab-uiyk, in conjunction with other antiretroviral drugs, 43% of patients achieved HIV RNA suppression.
Ibalizumab-uiyk was granted Fast Track, Priority Review, and Breakthrough Therapy designations from the FDA. In addition, it was granted Orphan Drug designation, a program that encourages the development of drugs to treat rare diseases.
Ibalizumab-uiyk is administered once every 14 days in conjunction with other retroviral medications.
The most common adverse reactions to ibalizumab-uiyk were diarrhea, dizziness, nausea, and rash. Less common, and more severe, reactions were changes in the immune system.
Ibalizumab-uiyk will be marketed by Taimed Biologics USA.
The Food and Drug Administration Feb. 6 approved ibalizumab-uiyk (Trogarzo) to treat multidrug-resistant HIV (MDR HIV) in adults, the agency announced.
“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,” Jeff Murray, MD, deputy director of the FDA Division of Antiviral Products, said in a statement. “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.”
Ibalizumab-uiyk, an HIV-1 inhibitor, was approved based on the results of a phase 3, single-arm study of 40 patients with MDR-HIV-1 who had high virus levels in their blood despite antiretroviral treatment. To be included in the study, all patients had to have received highly active antiretroviral therapy for at least 6 months prior. Over 24 weeks, patients were monitored to compare previous, infective treatments with ibalizumab-uiyk in conjunction with an optimized background regimen of antiretroviral drugs.
The majority of patients showed a significant decrease in their HIV-RNA levels 1 week after ibalizumab-uiyk was added to their previous drug regimens. After 24 weeks of treatment with ibalizumab-uiyk, in conjunction with other antiretroviral drugs, 43% of patients achieved HIV RNA suppression.
Ibalizumab-uiyk was granted Fast Track, Priority Review, and Breakthrough Therapy designations from the FDA. In addition, it was granted Orphan Drug designation, a program that encourages the development of drugs to treat rare diseases.
Ibalizumab-uiyk is administered once every 14 days in conjunction with other retroviral medications.
The most common adverse reactions to ibalizumab-uiyk were diarrhea, dizziness, nausea, and rash. Less common, and more severe, reactions were changes in the immune system.
Ibalizumab-uiyk will be marketed by Taimed Biologics USA.