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Theratechnologies' Novel AIDS Drug Filed In US

 
• By Alexandra Shimmings

Theratechnologies' partner TaiMed Biologics is seeking US approval of its novel antibody treatment for multidrug resistant HIV, ibalizumab, which offers a new therapy avenue for the increasing number of HIV patients who have worked through existing treatment options.

HIV virus
HIV in the Blood • Source: Shutterstock

Taiwan's TaiMed Biologics Inc. has made the first approval filing for its novel antibody treatment ibalizumab for use in multi-drug resistant HIV in the US, where it is licensed to Theratechnologies Inc. If successful, it would be the first new antiretroviral with a novel mode of action for nearly a decade, and the first that would not require daily dosing.

The submission is based on data from the Phase III TMB-301 study, a single arm, 24-week study of ibalizumab given on top of an optimized background regimen in treatment-experienced patients infected with multi-drug resistant HIV-1 presented earlier this year at the Conference on Retroviruses and Opportunistic Infections (see sidebar)

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