Jun 30, 2017
FDA Grants Priority Review to HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab
TaiMed Biologics, Inc. announced 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.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of January 3, 2017, for the ibalizumab application. Priority Review status accelerates FDA review time from 10 months to a goal of six months from the day of acceptance. In addition, ibalizumab received Breakthrough Therapy designation from the FDA in 2015, which is given if a therapy may provide a substantial improvement over what is currently available to address a serious and life-threatening condition. The FDA also granted Orphan Drug designation in 2014.
Source：TaiMed Biologics Inc.
http://www.taimedbiologics.com/news/info/68