TaiMed Biologics requested the approval of the weekly injectable antibody Ibalizumab For those with multidrug-resistant virus.
TaiMed Biologics has requested FDA approval for the weekly treatment of ibalizumab injectable antibodies for people with HIV resistant to multiple antiretrovirals. If approved, ibalizumab will have been the first treatment against HIV with a new way of attacking the virus to reach the market in 10 years, as well as the first treatment that did not require daily dosing.
TaiMed has developed ibalizumab, a humanized monoclonal antibody, in partnership with Theratechnologies.
The FDA has awarded ibalizumab an innovative therapy designation that is given to research therapies that can provide a substantial improvement over currently available treatments for a life-threatening health condition. TaiMed also requested a priority review designation from the FDA, which would expedite the review process.
The FDA application is based on data from the ibalbumab phase III study TMB-301, the results of which were presented at the 2017 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle in February.
The study included 40 people with HIV "Multidrug-resistant"Who were taking a daily ART regimen in bankruptcy or were not being treated for the virus. Additionally, they received 24 weeks of weekly intravenous ibalizumab injections.
The overall effectiveness rate of antibody treatment was probably impaired by the fact that nine participants (23 percent) did not complete the study. Four died for reasons unrelated to ibalizumab, three dropped out of the study and two were lost during follow-up. However, as is standard in this clinical research, the researchers included these individuals in their final analysis of treatment efficacy.
After the treatment period of 24 weeks, participants experienced an average fall in 40 times in viral load. Forty-eight percent experienced a fall greater than 100 times. Of those who were taking an optimized oral ART background, in addition to ibalizumab, 43 percent achieved an undetectable viral load; The mean viral load drop in this group was 1.260 times.
Translated by Claudio Souza Original in First Anti-Drug Treatment for HIV-Resistant May Get FDA Nod Published in 17 / 05 / 2017
reviewed by Mara Macedo.
To read, in English, the FDA press release, please click here.