Currently Viewing:
Newsroom
Currently Reading
Clinical Trial Participation Reduces Alcohol Intake, Improves HIV Outcomes in Women Regardless of Treatment Type
August 22, 2019 – Jaime Rosenberg
Hormone Replacement Therapy Might Place Some Menopausal Women at Increased Risk of Mortality
August 22, 2019 – Jaime Rosenberg
Results Point to Annual Assessment of Precursor to Multiple Myeloma
August 22, 2019 – Mary Caffrey
US Psoriasis Patients Face 2-Fold Mortality Risk, Study Finds
August 22, 2019 – Mary Caffrey
Air Pollution Found to Be Possible Cause of Premature Death Rates
August 22, 2019 – Matthew Gavidia
Elevated Troponin in Blood After Exercise Can Indicate Cardiovascular Disease, Study Finds
August 22, 2019 – Alison Rodriguez
What We're Reading: Gilead Challenges PrEP Patents; Opioid Addiction Treatment Use; NIH to Share Genetic Data
August 22, 2019 – AJMC Staff
More Women May Be Screened for BRCA Mutations Following USPSTF Guideline Update
August 21, 2019 – Jaime Rosenberg
MDM2 Antagonists Help CDK4/6 Inhibitors Overcome Resistance in Melanoma
August 21, 2019 – Laura Joszt

FDA Approves Trogarzo for Patients With Multidrug-Resistant HIV

Jaime Rosenberg
The FDA approved the antiretroviral medication for adult patients living with HIV who have been treated with multiple medications in the past and whose HIV infection did not respond to other currently available antiretroviral therapies.
The FDA has approved ibalizumab-uiyk (Trogarzo), a new HIV treatment for patients who have limited treatment options.

TaiMed Biologics’ antiretroviral medication gained approved for adult patients living with HIV who have been treated with multiple HIV medications in the past and whose HIV infection did not respond to currently available antiretroviral therapies.

“While most patients living with HIV can successfully be treated using a combination of 2 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 Jeff Murray, MD, deputy director, Division of Antiviral Products, FDA Center for Drug Evaluation and Research, 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.”

Ibalizumab-uiyk is administered intravenously once every 14 days and used in combination with other antiretroviral medications. The drug’s safety and efficacy were assessed in a clinical trial of 40 heavily treatment-experienced patients with MDR HIV-1 whose high levels of virus in their blood persisted despite being on antiretroviral medications. Some patients had been previously treated with 10 or more antiretroviral drugs.

A significant decrease in HIV-RNA levels were observed in the majority of patients a week after ibalizumab-uiyk was added to their treatment regimens. At 24 weeks, 43% of the patients achieved HIV RNA suppression. According to the FDA, the seriousness of the disease, the need to individualize other drugs in the treatment regimen, and safety data from other trials were considered in evaluating the ibalizumab-uiyk development program.

The FDA granted the application Fast Track, Priority Review, Breakthrough Therapy, and Orphan Drug designations.

Related Articles

Today's HIV Treatment Challenges
HIV Guideline Update
NCCN Releases Guidelines to Address Treatment Gaps for People With HIV and Cancer
CDC Releases Trends in HIV Diagnoses Among Adolescents, Young Adults From 2010 to 2014
HIV Treatment Initiation and Resistance Testing
 
Copyright AJMC 2006-2019 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up