ViiV Healthcare completes filing for FDA approval of fostemsavir

A New Drug Application (NDA) submission to the US Food and Drug Administration seeking approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV-1 infection has been completed by specialist HIV company ViiV Healthcare, which is majority-owned by UK pharma major GlaxoSmithKline (LSE: GSK).

Fostemsavir, which in 2015 was acquired from Bristol-Myers Squibb (NYSE: BMY) as part of an asset purchase deal worth $1.4 billion, is being developed for use in combination 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.

While under the ownership of the US pharma major, fostemsavir received Breakthrough Therapy designation from the US FDA and at that time was expected to be filed for regulatory approval in 2018.