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

RJHS – 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
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

References:

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 Systems Inc Reimbursement Codes https://www.reimbursementcodes.com Accessed March 6, 2016.

Global Data Pharma Intelligence Center https://pharma.globaldata.com Accessed February 19, 2018.