Posted by Michael Wonder on 01 Jul 2017
FDA grants priority review to HIV monoclonal antibody and long-acting investigational anti-retroviral ibalizumab
30 June 2017 - Biologics license application accepted for review with a target action date of 3 January 2018.
Theratechnologies today announced that it has been notified by its partner, TaiMed Biologics that the U.S. FDA has accepted for review the biologics license application for ibalizumab as a treatment for multi-drug resistant human immunodeficiency virus-1.
If approved, ibalizumab will be the first anti-retroviral treatment with a new mechanism of action to be introduced in nearly 10 years and the only treatment that does not require daily dosing.
