FDA greenlights alternative therapy for multidrug-resistant HIV patients

Theratechnologies has revealed that Trogarzo has received approval from the FDA as a treatment of HIV-1 in patients with multidrug-resistant infection.

The regulator’s decision was based on Phase 3 data which showed that Trogarzo "significantly reduced" viral load within seven days of the first dose, maintaining response when used in conjunction with an optimized background regimen that included at least one other active ART for up to 24 weeks of treatment. More than 80% of participants achieved at least a 0.5 log or 70% reduction in viral load from baseline from a 2,000mg dose after seven days, with no change to the failing background regimen.

After 24 weeks of treatment, average viral load reduction stood at 1.6 log, while 43% of patients achieved undetectable levels of viral load.

It is estimated that around 25,000 HIV patients in the US are multidrug-resistant, with 12,000 whose treatment is not effective enough and causing their viral load to rise and put their health and the health of others at risk, highlighting the need for alternative treatment solutions.

"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," commented 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. New treatment options may be able to improve their outcomes."

It is estimated that around 25,000 HIV patients in the US are multidrug-resistant, with 12,000 whose treatment is not effective enough and causing their viral load to rise and put their health and the health of others at risk, highlighting the need for alternative treatment solutions.

"Today's approval of Trogarzo by the FDA is great news for people infected with difficult-to-treat multidrug resistant HIV. We look forward to bringing this much-needed therapy to patients in the US within six weeks," said Luc Tanguay, President and Chief Executive Officer at Theratechnologies. "We are grateful to the patients, investigators, as well as the FDA who supported the clinical development of Trogarzo, and are helping address this critical unmet medical need."

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