Theratechnologies states FDA approval of innovative therapy, Trogarzo Injection
Theratechnologies and its partner TaiMed Biologics, Inc. (TaiMed) asserted that the U.S. Food and Drug Administration (FDA) has granted approval of Trogarzo (ibalizumab-uiyk) Injection. In combination with other ARTs, Trogarzo is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
Trogarzo™ represents a critical new treatment advance as the first HIV therapy with a new mechanism of action approved in 10 years and proven effectiveness in difficult-to-treat patients with limited options. Unlike all other classes of ARTs, Trogarzo™ is a CD4-directed post-attachment HIV-1 inhibitor that binds to CD4+ receptors on host cells and blocks the HIV virus from infecting the cells.
Luc Tanguay, President and Chief Executive Officer, Theratechnologies Inc said “We are grateful to the patients, investigators, as well as the FDA who supported the clinical development of Trogarzo™, and are helping address this critical unmet medical need.”