Last month, the FDA approved Trogarzo, and granted the new antiretroviral drug Fast Track, Priority Review, and Breakthrough Therapy designations, which expedite the development and review of drugs to treat serious conditions.  For Breakthrough Therapy designation to be assigned by the FDA, preliminary clinical evidence must indicate that the drug may demonstrate substantial improvement over available therapies.

Specifically, Trogarzo is designed to treat adult patients whose HIV infections cannot be successfully treated with other currently available therapies.  Jeff Murray, M.D., Deputy Director of the Division of Antiviral Products, explains that, “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.”  Most patients living with HIV can be successfully treated using a combination of two or more antiretroviral drugs.  Trogarzo would significantly enhance the treatment options for the minority of patients who are heavily treatment-experienced with multidrug resistant HIV.

The majority of the 40 heavily treatment-experienced patients who participated in the clinical trial designed to test the efficacy and safety of Trogarzo experienced a signficant decreased in their HIV-RNA levels one week after Trogarzo was added to their antiretroviral regimens.  Nearly half of the trial’s participants achieved HIV RNA suppression after 24 weeks of receiving Trogarzo along with other antiretroviral drugs.

Read more about Trogarzo in the FDA’s News Release.