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# ViiV Files NDA for HIV Drug
- URL: https://www.fdaweb.com/viiv-files-nda-for-hiv-drug/
- Published: 2019-12-05T12:00:00.000Z
- Updated: 2026-09-14T15:55:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145659

ViiV Healthcare has submitted an NDA for fostemsavir, an investigational, first-in-class attachment inhibitor for treating HIV-1 infection. The drug is under development for combination use with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a suppressive regimen due to resistance, intolerance or safety considerations.

The submission is based on data from the pivotal Phase 3 BRIGHTE study in heavily treatment-experienced people living with multidrug-resistant HIV. The primary endpoint analysis demonstrated superiority of fostemsavir to placebo, the company says. The most common adverse reactions were nausea and diarrhoea.