New HIV treatment drug Trogarzo received approval on Tuesday from the FDA, which said the drug is for “patients with limited treatment options.”
In its release e-mail, the FDA defined those patients as those with HIV “who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV).”
Trogarzo is given intravenously along with other antiretroviral drugs.
In a clinical trial, 40 people who fit the description were given Trogarzo, which is made by TaiMed Biologics USA. Many of the 40 had gone through treatments with at least 10 antiretroviral drugs.
“The majority of participants experienced a significant decrease in their HIV-RNA levels one week after Trogarzo was added to their failing antiretroviral regimens,” the FDA said. “After 24 weeks of Trogarzo plus other antiretroviral drugs, 43 percent of the trial’s participants achieved HIV RNA suppression.”
The most common side effect in the 292 people with HIV-1 who have taken Trogarzo were diarrhea, dizziness, nausea and rash. Severe rash and immune system changes were the harshest side effects.
“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 a statement by Dr. Jeff Murray, 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.”