Extremely important news has come from Montreal, Canada carrying the announcement by Theratechnologies (TSX:TH) and its partner TaiMed Biologics (TaiMed) that the FDA has granted approval of Trogarzo™ (ibalizumab- uiyk) Injection. The approval is for Trogarzo to be used with other ARTs for HIV-1 infection in heavily treated adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
Trogarzo™ is a humanized monoclonal antibody created for multidrug resistant HIV-1 infection. The drug binds primarily to the second extracellular domain of the CD4+ T receptor, away from major histocompatibility complex II molecule binding sites. It prevents HIV from infecting CD4+ immune cells while preserving normal immunological function. Trogarzo™ is a prescription HIV medicine that is used with other antiretroviral medicines to treat human immunodeficiency virus-1 (HIV-1) infections in adults. The product represents the first HIV therapy with a new mechanism of action approved in 10 years and proven effectiveness in difficult-to-treat patients with limited options.
Previously, the FDA granted Trogarzo Breakthrough Therapy and Orphan Drug designations as well as Priority Review status.
Up to 25,000 Americans with HIV are currently multidrug resistant, of which 12,000 are in pressing 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.2-13
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.”
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 trials, we saw marked improvements in patients’ health who not only were heavily treatment-experienced and had limited remaining treatment options but in cases where they also had extremely high viral loads and significantly impaired immune systems,” said Edwin DeJesus, M.D., Medical Director for the Orlando Immunology Center. “As an investigator for Trogarzo clinical trials over nearly 10 years, it was remarkable and inspiring to see the dramatic effect the drug 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.”
Clinical studies show that Trogarzo, in combination with other ARTs, significantly reduces viral load and increases CD4+ (T-cell) count among patients with multidrug resistant HIV-1.
In Phase 3 trial, Trogarzo has demonstrated a significantly reduced viral load within seven days after the first dose of functional mono-therapy and maintained the treatment response when combined with an optimized background regimen that included at least one other active ART for up to 24 weeks of treatment, while being safe and well tolerated.
More than 80% of patients achieved the study’s primary endpoint – at least a 0.5 log (or 70%) viral load reduction from baseline seven days after receiving a 2,000 mg loading dose of Trogarzo and no adjustment to the failing background regimen.
Patients experienced a clinically-significant mean increase in CD4+ T-cells of 44 cells/mm, and increases varied based on the T-cell count at baseline. Rebuilding the immune system by increasing T-cell count is particularly important as people with multidrug resistant HIV-1 often have the most advanced form of HIV.1
The most common drug-related adverse reactions (incidence ≥ 5%) were diarrhea (8%), dizziness (8%), nausea (5%) and rash (5%). No drug-drug interactions were reported with other ARTs or medications, and no cross-resistance with other ARTs were observed.1
Trogarzo blocks HIV from infecting certain cells of the immune system. This prevents HIV from multiplying and can reduce the amount of HIV in the body.
The FDA approval of is great news for people infected with multidrug resistant HIV. The news about the FDA approval of Trogarzo brings hope and life to those whose HIV infection is resistant to the current treatments. The new drug empowers the current treatment regimens that have already transformed a killer infection into a chronic treatable disease.
It is important, though that infected people with the resistant virus who are prescribed Trogarzo to read the instructions and abide by them and to consult with their treating physicians about any problem they encounter while on Trogarzo.
The approval of Trogarzo, no doubt about it, is worth celebrating.
Other important news from Prohost… our picked firms will be posted with explanations in the Prohost The Week In Review to be posted Monday.
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