Dec 05, 2019: ViiV Healthcare have completed submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) in search of approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV-1 infection.
Fostemsavir is being developed for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are not able to form a oppressive regimen due to resistance, intolerance or safety considerations.
For the people living with HIV Fostemsavir may provide an imperative treatment option for the group.
This submission is supported by the data from the pivotal phase III BRIGHTE study in significantly treatment-experienced people living with multidrug-resistant HIV.
The results (96-week) from the BRIGHTE study were most recently presented in July at the 10th International AIDS Society Conference on HIV Science (IAS 2019) in Mexico City. https://viivhealthcare.com/en-us/us-news/us-articles/2019/viiv-healthcare-submits-new-drug-application-to-the-fda-for-fost/