FDA grant priority review for ibalizumab
10 August 2017. Related: Antiretrovirals.
Simon Collins, HIV i-Base
On 30 June 2017, Theratechnologies issued a press release about the US FDA decision to accept a priority review for ibalizumab, a monoclonal antibody currently in phase 3 studies as a treatment for multidrug resistant HIV.
The FDA also set a timeline of January 2018 to receive the application. Priority review reduces the time taken to review the application, once submitted, from approximately 10 months to 6 months.
The review was based on phase 3 results from the single arm, 24-week TMB-301 study that used ibalizumab in addition to optimised background ART in people with drug resistance to at drugs from at least three classes.
Ibalizumab is an HIV entry inhibitor that is given by infusion every two weeks. It was also designated a breakthrough therapy by the FDA in 2015 and was granted Orphan Drug designation in 2014.
Ibalizumab is being developed by TaiMed Biologics, but with be marketed and distributed by Theratechnologies in the US
FDA grants priority review to HIV monoclonal antibody and long-acting investigational antiretroviral ibalizumab. (30 June 2017)