The U.S. Food and Drug Administration approved TaiMed Biologics Inc.'s Trogarzo to treat certain adults with HIV.
The regulator granted the approval for the drug to TaiMed Biologics USA Corp. for the treatment of adult patients with HIV-1 who have tried multiple HIV medications in the past and whose HIV infections cannot be successfully treated with other currently available therapies.
Trogarzo is administered into a vein once every 14 days by a trained medical professional and used in combination with other antiretroviral medications. The drug attaches to the CD4+ protein molecules on host cells and blocks the HIV virus from infecting the cells.
Antiretroviral drugs are medications that do not kill or cure the HIV virus but can slow down or prevent its growth.
The safety and efficacy of the drug were tested in a study that involved 40 heavily pretreated patients with multidrug-resistant HIV-1 infection who continued to have high levels of virus in their blood despite antiretroviral therapy. In the trial, 43% of patients experienced suppressed levels of the HIV virus in the body.
Viral suppression is reached when the level of HIV in the blood is very low and undetectable, though it does not mean a person is cured as HIV still remains in the body.
TaiMed's partner Theratechnologies Inc. owns commercialization rights for the drug in the U.S., Canada, EU, Israel, Norway, Russia and Switzerland.
