(RxWiki News) The US Food and Drug Administration (FDA) has approved a new drug to treat HIV.
The new approval is for Trogarzo (ibalizumab-uiyk). The FDA approved this medication to treat HIV that has not been successfully treated with other medications (multidrug-resistant HIV). Patients with multidrug-resistant HIV have limited treatment options and are at high risk of HIV-related complications.
Unlike most anti-HIV medications that come in a pill form, this medication is administered into a vein (IV) by a trained health care professional once every 14 days. Trogarzo is to be given in combination with other anti-HIV medications.
“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," said Dr. Jeff Murray, deputy director of the FDA's Division of Antiviral Products, in a press release. "New treatment options may be able to improve their outcomes."
The safety and effectiveness of Trogarzo was evaluated in a trial of 40 patients with multidrug-resistant HIV. Many of these patients had tried 10 or more anti-HIV medications.
After being treated with Trogarzo in combination with other anti-HIV medications for 24 weeks, 43 percent of these patients saw their level of HIV virus decrease to an undetectable level. Common side effects of Trogarzo included diarrhea, dizziness, nausea and rash.
The FDA granted the approval of Trogarzo to TaiMed Biologics USA Corp.