Review of ibalizumab-uiyk (TrogarzoTM) a novel biologic for patients with multi-drug resistant HIV-1
Multi-drug resistant HIV (MDR-HIV) carries a greater risk of disease progression and leaves HIV patients with limited treatment options.
There are currently 10,000 people living with MDR-HIV in the United States, and due to this prevalence, it has become necessary to consider drug candidates with new mechanisms of action in order to offer a solution to the current drug resistance issue.
Ibalizumab-uiyk is a monoclonal antibody biologic developed for the treatment of patients with multi-drug resistant HIV-1 (MDR-HIV). This biologic, developed by TaiMed Biologics Inc., belongs to a new drug class called viral entry inhibitors, and has shown promising preliminary results in Phase III trials.
For our complete review of ibalizumab-uiyk :
Executive Summary of Evaluation:
| Ibalizumab-uiyk (TaiMed Biologics Inc.) | ||
| Regulatory
|
Status | Approved March 6, 2018 |
| PDUFA | 4/3/2018 | |
| Orphan Drug Designation | 10/20/2014 | |
| Breakthrough Therapy Designation | 2/27/2015 | |
| FDA Priority Review | 6/30/17 | |
| Patent Expiration | 11/11/2031 | |
| Indications | Multi-Drug Resistant HIV-1 | Approved (BLA) |
| Efficacy | Multi-Drug Resistant HIV-1 | Efficacy reported in Phase III Trials |
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.
NIH U.S. National Library of Medicine ClinicalTrails.gov https://clinicaltrials.gov/ct2/home Accessed: February 26, 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.
Pharma Intelligence Center https://pharma.globaldata.com Accessed: February 19, 2018.
CDC Centers for Disease Control and Prevention. HIV/AIDS. https://www.cdc.gov/hiv/statistics/overview/ataglance.html Accessed: March 2, 2108.
Coauthored by: Kristen Ciampi, PharmD Candidate
Kristen is a sixth-year pharmacy student at the University of Rhode Island. Kristen is completing her studies through an advanced pharmacy practice rotation at RJ Health Systems prior to graduating with a PharmD degree in May of 2018.
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