FDA Greenlights New Treatment for Multi-Drug Resistant HIV-1


Shares of Theratechnologies Inc. and TaiMed Biologics jumped Tuesday after the U.S. Food and Drug Administration green lit Trogarzo (ibalizumab), the first HIV-1 inhibitor for patients with multi-drug resistant HIV-1.

Like many other new drugs hitting the markets, Trogarzo is designed in part to provide greater quality of life to patients. The companies said the newly approved treatment is the only antiretroviral medicine that does not require daily dosing. Trogarzo is administered intravenously once every 14 days. It is being used in combination with other antiretroviral treatments. In its announcement, the two companies noted that Trogarzo is the first new HIV therapy with a new mechanism of action in 10 years.

Trogarzo, which was co-developed by TaiMed Biologics and Theratechnologies, is a CD4-directed post-attachment HIV-1 inhibitor that binds to CD4+ receptors on host cells and blocks the HIV virus from infecting the cells.

Trogarzo was approved by the FDA based on data from a clinical trial of 40 heavily treatment-experienced patients with multi-drug resistant HIV-1 who continued to have high levels of virus (HIV-RNA) in their blood despite being on antiretroviral drugs. The FDA said many of those patients had previously been treated with 10 or more antiretroviral drugs. When Trogarzo was added to the regimen the FDA said the majority of participants “experienced a significant decrease in their HIV-RNA levels” one week after the new drug was added to their regimen. After 24 weeks of Trogarzo plus other antiretroviral drugs, 43 percent of the trial’s participants achieved HIV RNA suppression, the FDA noted.

Jeff Murray, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research, said Trogarzo can “provide significant benefit to patients who have run out of HIV treatment options.”

The approval provides a new treatment for about 25,000 HIV patients who are classified as multi-drug resistant. Of those patients, just under half, about 12,000, need a new treatment option. In its announcement Theratechnologies said failing drug regimens have caused their viral load to rise to detectable levels, jeopardizing their health and making HIV transmittable. According to new guidance from the U.S. Centers for Disease Control and Prevention, the HIV virus cannot be transmitted if it is being fully suppressed.

David Ho, an advisor to TaiMed and chief executive officer of the Aaron Diamond AIDS Research Center, recalled the days when a diagnosis of HIV was tantamount to a death sentence.

“Since then, treatment advances and the discovery that combinations of ARTs was the best way to bring viral load below the level of detection have allowed most people to manage HIV like a chronic condition and live long healthy lives. However, this is not the reality for people whose HIV is resistant to multiple drugs and whose viral load is not controlled, which is why TaiMed dedicated the past decade to advancing ibalizumab in the clinic. For these patients, it represents the next breakthrough,” Ho said in a statement.

During development, Trogarzo was granted Fast Track, Priority Review and Breakthrough Therapy designations by the FDA. Additionally, Trogarzo received Orphan Drug designation.

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