|Source||Humanized (from mouse)|
|Other names||Ibalizumab-uiyk; TMB-355, TNX-355|
|Side effects||Rash, diarrhea, dizziness, headache, nausea, tiredness|
|(what is this?)|
Ibalizumab, sold under the brand name Trogarzo, is a medication used to treat HIV/AIDS. It is used, together with other medications, when standard treatments are not effective. It is given by injection into a vein.
Common side effects include rash, diarrhea, dizziness, headache, nausea, and tiredness. Other side effects may include immune reconstitution syndrome. Safety in pregnancy is unclear. It is a monoclonal antibody that binds to CD4 and prevents HIV from entering cells.
Ibalizumab was approved for medical use in the United States in 2018 and Europe in 2019. In the United States the initial dose costs about 13,400 USD, with further treatment about 11,000 USD per month as of 2021. It is not commercially available in the United Kingdom and Europe as of 2021.
It is given at an initial dose of 2,000 mg and than given as 800 mg every two weeks.
Ibalizumab is being developed by TaiMed Biologics but was originally developed by Tanox, now part of Genentech. As part of Genentech's takeover of Tanox, the patent for ibalizumab was sold to TaiMed Biologics, a biotech company formed in 2007 with support from the Taiwanese Government through a $20 million investment by the state-owned National Development Fund.
Milestones for the intravenous (i.v.) infusion dosage form:
- 2003: completed a phase-1a clinical trial for i.v. infusion dosage form.
- 2003: granted fast track status by U.S. FDA.
- 2003: completed a phase-1b clinical trial for i.v. infusion dosage form.
- 2006: completed a phase-2a clinical trial for i.v. infusion dosage form.
- 2011: completed a phase-2b clinical trial for i.v. infusion dosage form.
- 2012: completed a phase-1 clinical trial for s.c. injection dosage form.
- 2013: initiated a phase-1/2 clinical trial for s.c. and i.m. injection dosage forms (on-going).
- 2014: granted orphan drug designation for HIV MDR patients by U.S. FDA.
- 2015: granted breakthrough therapy designation for i.v. infusion dosage form by U.S. FDA.
- 2015: initiated a phase-3 clinical trial for i.v. infusion dosage form (on-going).
- 2016: initiated and intended to complete a rolling BLA submission for i.v. infusion dosage form to U.S. FDA.
- 2016: completion of a phase-3 clinical trial for i.v. infusion dosage form
- 2017: completion of BLA submission and pre-approval inspection for i.v. infusion dosage form to U.S. FDA
- 2018: U.S. market approval (trade name: Trogarzo)
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