Drug Alert – FDA Approval – Ibalizumab-uiyk (TrogarzoTM)

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.

To be notified of this and future publications, please sign up for RJ Drug Alerts.

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
Labeled Indication:
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
62064-0122-02 200mg/1.33ml (150mg/ml) 1.33ml SDV Refrigeration
Drug Sales Forecast (in millions):
  2018(F) 2019(F) 2020(F) 2021(F) 2022(F) 2023(F)
TrogarzoTM $67 $168 $272 $367 $467 $566


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.