Type of information: Acceptation for review of a NDA
Product name: ibalizumab
Therapeutic area: Infectious diseases
Action mechanism: monoclonal antibody. Ibalizumab is a CD4-directed HIV entry-inhibitor and is the first humanized monoclonal antibody in clinical trials for the treatment of HIV. Ibalizumab was designated a Breakthrough Therapy by the FDA based on preliminary clinical evidence indicating that it may represent a substantial improvement over existing therapies on one or more clinically significant endpoints. In a Phase IIb clinical trial, conducted on 113 patients, the product significantly reduced viral load in multi-drug resistant HIV-infected patients.
The US FDA has also granted ibalizumab Orphan Drug designation.
Company: TaiMed Biologics (Taiwan) Theratechnologies (Canada)
Disease: HIV-1 infection in treatment experienced adult patients with documented multi-antiretroviral class resistance and evidence of HIV-1 replication despite ongoing antiretroviral therapy
- • On June 30, 2017, Theratechnologies announced that it has been notified by its partner, TaiMed Biologics., that the 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, 2018, 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.
- • On May 3, 2017, Theratechnologies announced that its partner, TaiMed Biologics, has completed the submission of a Biologics License Application (BLA) to the FDA for ibalizumab for the treatment of multidrug resistant 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. As ibalizumab has received the Breakthrough Therapy and Orphan Drug Designations, TaiMed has requested Priority Review for the application.
- The ibalizumab BLA is based on data from the phase III TMB-301 study, a single arm, 24-week study of ibalizumab plus an optimized background regimen in treatment-experienced patients infected with MDR HIV-1. Full results from the trial were recently presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2017.
- • On October 20, 2014, the FDA has granted orphan drug designation for ibalizumab for the treatment of HIV-1 infection in treatment experienced adult patients with documented multi-antiretroviral class resistance and evidence of HIV-1 replication despite ongoing antiretroviral therapy.
Submission of marketing authorization application USA : 2017-05-03
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2014-10-20
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: