Posted by Michael Wonder on 05 Dec 2019
ViiV Healthcare submits new drug application to the FDA for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available
5 December 2019 - ViiV Healthcare today completed submission of a new drug application to the US FDA seeking 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 anti-retroviral 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.
This submission is supported by the data from the pivotal phase III BRIGHTE study in heavily treatment-experienced people living with multidrug-resistant HIV.
