FDA Application Accepted for HIV Drug with New Mechanism of Action
Theratechnologies Inc. (Theratechnologies) (TSX: TH) announced Friday that it has been notified by its partner, TaiMed Biologics, Inc., that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ibalizumab as a treatment for 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. “We are excited to be one step closer to potentially bringing an important new treatment, with a new mechanism […]