RJH – Drug Alert
FDA Drug Approval – Ibalizumab-uiyk (TrogarzoTM)
On March 6, 2018, the U.S. Food and Drug Administration (FDA) approved a first in class treatment for adults with multi-drug resistant (MDR) HIV-1 infection, with a manufacturer’s initial estimated annual treatment cost of $118,000.
An initial overview is listed below. For additional Information on ibalizumab-uiyk, watch for our more detailed therapy review to be published later this month.
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|Generic Name||Brand Name||Manufacturer||Approval Date||Anticipated Availability||Accelerated Review|
|Ibalizumab-uiyk||TrogarzoTM||TaiMed Biologics USA Corp||March 6, 2018||Mid-April 2018||Yes|
|Treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant (MDR) HIV-1 infection failing their current antiretroviral regimen.|
|Drug Class:||Comparative Drugs in Class:||Route of Administration:||Dosing Schedule:|
|Viral Entry Inhibitors / Fusion Inhibitor||None – Innovator||Intravenous||Every 2 weeks|
|Mechanism of Action:|
|Ibalizumab-uiyk blocks HIV-1 from infecting CD4+ T cells by binding to domain 2 of CD4 and interfering with post-attachment steps required for the entry of HIV-1 virus particles into host cells thus preventing the viral transmission that occurs via cell-cell fusion.|
|Clinical Trial Summary:|
|The safety and efficacy of Ibalizumab-uiyk was evaluated in a clinical trial of 40 heavily treatment-experienced patients with MDR HIV-1 who continued to have high levels of virus (HIV-RNA) in their blood despite being on antiretroviral treatment (ART). The majority of participants (33 or 83%) experienced a significant decrease in their HIV-RNA levels one week after Ibalizumab-uiyk was added to their failing antiretroviral regimens. After 24 weeks of Ibalizumab-uiyk plus other antiretroviral drugs, 43 percent of the trial’s participants achieved HIV RNA suppression.|
|Warnings and Adverse Effects (AE):|
|Warning: Severe side effects included rash and changes in the immune system (immune reconstitution syndrome).|
|AE: The most common adverse reactions were diarrhea (8%), dizziness (8%), nausea (5%) and rash (5%).|
|NDC||Strength||Volume||Single Dose Vial (SDV) / (Multi Dose Vial (MDV)||Storage|
|Drug Sales Forecast (in millions):|
U.S. Food and Drug Administration FDA News Release https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm599657.htm?utm_campaign=FDA%20approves%20new%20HIV%20treatment%20-%20Drug%20Information%20Update&utm_medium=email&utm_source=Eloqua Accessed March 6, 2017.
Thera technologies TrgarzoTM https://www.multivu.com/players/English/8154151-theratechnologies-ibalizumab-fda-approval/ Accessed March 7, 2018.
Theratechnologies Announces FDA Approval of Breakthrough Therapy, Trogarzo™ (ibalizumab-uiyk) Injection, the First HIV-1 Inhibitor and Long-Acting Monoclonal Antibody for Multidrug Resistant HIV-1 https://www.prnewswire.com/news-releases/theratechnologies-announces-fda-approval-of-breakthrough-therapy-trogarzo-ibalizumab-uiyk-injection-the-first-hiv-1-inhibitor-and-long-acting-monoclonal-antibody-for-multidrug-resistant-hiv-1-300609280.html Accessed March 7, 2018.
“New Drug Benefits Patients with Multi-Drug Resistant HIV.” IDSA: Infectious Diseases Society of America, 28 Oct. 2016, www.idsociety.org/Press_Release_10_28_2016/. Accessed February 28, 2018.
RJ Health Reimbursement Codes https://www.reimbursementcodes.com Accessed March 6, 2016.
Global Data Pharma Intelligence Center https://pharma.globaldata.com Accessed February 19, 2018.