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From staff reports
Theratechnologies Inc. and its partner TaiMed Biologics Inc. announced Tuesday, March 6 that the FDA has granted approval of Trogarzo injection.
In combination with other antiretroviral therapies (ARTs), Trogarzo (ibalizumab-uiyk) is indicated for the treatment of HIV in heavily treatment-experienced adults with multidrug-resistant infections who are failing their current regimens.
Trogarzo is the first HIV therapy with a new mechanism of action approved in 10 years, and it has proven to be effective in difficult-to-treat patients with limited options.
“Today’s approval of Trogarzo by the FDA is great news for people infected with difficult-to-treat, multidrug-resistant HIV,” said Luc Tanguay, president and CEO of Theratechnologies Inc. “We look forward to bringing this much-needed therapy to patients in the U.S within six weeks.”
Trogarzo previously received Breakthrough Therapy and Orphan Drug designations as well as Priority Review status from the FDA, underscoring the significance of the treatment for this patient population.
“I witnessed some of the earliest cases of HIV and AIDS, at a time when the diagnosis was terrifying to patients because in many cases it was a death sentence,” said Dr. David Ho, chief scientific advisor of TaiMed and scientific director and CEO of the Aaron Diamond AIDS Research Center. “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.”
Up to 25,000 Americans with HIV are currently multidrug-resistant, and nearly 12,000 are in urgent need of a new treatment option because their current treatment regimen is failing them and their viral load has risen to detectable levels, jeopardizing their health and making HIV transmittable. The best way to prevent the transmission of multidrug-resistant HIV is to control the virus in those living with it.
According to new guidance from the Centers for Disease Control and Prevention (CDC), the HIV virus cannot be transmitted if it is being fully suppressed.
“I’ve struggled with multidrug-resistant HIV for almost 30 years, and it was completely debilitating to feel like I had run out of options—I made no long-term plans,” said Nelson Vergel, founder of the Program for Wellness Restoration (PoWeR) and a Trogarzo patient. “Since starting treatment with Trogarzo six years ago and getting my viral load to an undetectable level, I have been my happiest, most productive self. Trogarzo is a new source of hope and peace of mind for people whose treatments have failed them, and I feel incredibly lucky to have been able to participate in the clinical trial program.”
TaiMed and Theratechnologies partnered on the development of Trogarzo so patients who can benefit from the treatment have access to it. For patients who need assistance accessing Trogarzo or who face challenges affording medicines, Theratechnologies has a team of patient care coordinators available to help. Patients can get assistance and expert support by contacting THERA patient support at 1-833-23-THERA (84372).
“In Phase 3 ibalizumab trials, we saw marked improvements in patients’ health who not only were heavily treatment-experienced and had limited remaining treatment options, but in cases they also had extremely high viral loads and significantly impaired immune systems,” said Dr. Edwin DeJesus, medical director for the Orlando Immunology Center. “As an investigator for ibalizumab clinical trials over nearly 10 years, it was remarkable and inspiring to see the dramatic effect ibalizumab had on such vulnerable patients. As a clinician, I am excited that we will now have another option with a different mechanism of action for our heavily pretreated patients who are struggling to keep their viral load below detection because their HIV is resistant to multiple drugs.”