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# FDA Accepts Theratechnologies BLA for HIV-1
- URL: https://www.fdaweb.com/fda-accepts-theratechnologies-bla-for-hiv-1/
- Published: 2017-06-30T12:00:00.000Z
- Updated: 2026-09-14T22:32:39.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5139072

FDA has accepted for review a Theratechnologies BLA for ibalizumab as a treatment for multidrug resistant human immunodeficiency virus-1\. The company says that, if approved, ibalizumab will be the first antiretroviral treatment with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing. The agency has set a user fee review action target date of 1/3/2018.

  
The submission is based on data from the Phase III TMB-301 study, a single arm, 24-week study of ibalizumab plus an optimized background regimen in treatment-experienced patients who had high pre-existing levels of drug resistance and advanced clinical disease. The humanized monoclonal antibody works by binding to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites, the company says. “It potentially prevents HIV from infecting CD4-positive immune cells while preserving normal immunological function,” it adds.