The Biologics License Application for ibalizumab is under review for the treatment of multidrug resistant HIV-1.
The FDA recently granted priority review for ibalizumab for the treatment of multidrug resistant HIV-1.
Ibalizumab is an investigational humanized monoclonal antibody designed to bind to the second extracellular domain of the CD4+ T cell receptor, according to a press release.
If ibalizumab is approved, it will be the first antiretroviral treatment (ART) with a new mechanism of action to be introduced in nearly a decade. Furthermore, it is the only treatment that does not require daily dosing.
“We are excited to be one step closer to potentially bringing an important new treatment, with a new mechanism of action, to patients whose virus has become resistant to therapies in multiple classes and have limited treatment options for the long-term management of their condition,” Luc Tanguay, president and CEO of Theratechnologies Inc, said in a release. “The granting of Priority Review status is important since it confirms that, if approved, ibalizumab would represent a significant improvement in the treatment of this serious condition.”
The Biologics License Application (BLA) for ibalizumab is based on data from the single-arm, 24-week, phase 3 TMB-301 study, which examined ibalizumab plus an optimized background regimen in treatment-experienced patients with high preexisting levels of drug resistance and advanced clinical disease.
Ibalizumab Expanded Access Program is currently enrolling new patients.
The FDA set a target action date of January 3, 2018 for the ibalizumab BLA, according to the release. Additionally, ibalizumab received Breakthrough Therapy designation from the FDA in 2015 and Orphan Drug designation in 2014.
In the United States, an estimated 20,000 to 25,000 individuals with HIV-1 are resistant to at least 1 drug out of 3 different classes of ART. Of these patients, up to 12,000 experience a virological failure over a 48-week treatment period, causing physicians to modify their treatment.