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TaiMed's Trogarzo Is US FDA's First HIV/AIDS Breakthrough Approval

 
• By Bridget Silverman

Unusual review of ibalizumab-uiyk marks other HIV firsts too: first monoclonal antibody and first new mechanism of action in 10 years. Company considered several routes of administration, and the Phase III trial was actually smaller than the Phase II study.

Immune system attacking HIV

HIV was the crucible for the concept of expedited approval pathways, but drug development in the field has largely remained in a mature consolidation phase for the past decade. Indeed, the US FDA's recent approval of TaiMed Biologics Inc.'s Trogarzo (ibalizumab-uiyk) is notable not only as the first HIV approval to carry a breakthrough therapy designation (BTD), but also as the first new mechanism of action to reach the market for HIV therapy in 10 years.

FDA approved the CD4-directed post-attachment HIV-1 inhibitor Trogarzo on March 6, 2018 for treatment of heavily treatment-experienced adults whose multidrug resistant (MDR) HIV infection cannot be successfully treated with other...

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