Ibalizumab filed with FDA for multidrug resistant Human Immunodeficiency Virus-1 - Theratechnologies

Theratechnologies announced that its partner, TaiMed Biologics, has completed the submission of a Biologics License Application to the FDA for ibalizumab for the treatment of multidrug resistant Human Immunodeficiency Virus-1 (MDR HIV-1). If approved, ibalizumab will be the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing. As ibalizumab has received the Breakthrough Therapy and Orphan Drug Designations, TaiMed has requested Priority Review for the application.

The ibalizumab BLA is based on data from the phase III TMB-301 study, a single arm, 24-week study of ibalizumab plus an optimized background regimen (OBR) in treatment-experienced patients infected with MDR HIV-1. Full results from the trial were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2017.

Comment: TMB-301 was a single arm, 24-week study of ibalizumab plus optimized background regimen (OBR) in 40 treatment-experienced patients infected with multidrug resistant HIV-1. Patients receiving their current failing antiretroviral therapy (ART), or no therapy, were monitored during a seven-day control period. Thereafter, a single loading dose of 2,000 mg of intravenous (IV) ibalizumab was the only ART added to their regimen. The primary efficacy endpoint was the proportion of patients achieving at least 0.5 log10 decrease in HIV-1 RNA seven days after initiating ibalizumab therapy, day 14 of the study. Ibalizumab was continued at doses of 800 mg IV every two weeks through 24 weeks on study treatment.