ViiV Healthcare is seeking approval from the US Food and Drug Administration (FDA) for its fostemsavir to treat HIV-1 infection.
The company has completed the submission of a new drug application (NDA) to the regulator for fostemsavir.
Fostemsavir, an investigational prodrug of temsavir, is a first-in-class HIV-1 attachment inhibitor of the HIV-1. It works by binding directly to the glycoprotein 120 (gp120) subunit on the surface of the virus.
The company is developing fostemsavir for use in combination with other antiretroviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who cannot form a suppressive regimen due to resistance, intolerance or safety considerations.
ViiV has submitted the NDA based on the data from the pivotal phase III BRIGHTE study in heavily treatment-experienced people living with multidrug-resistant HIV.
BRIGHTE is a phase III, partially-randomised international, double-blind and placebo-controlled trial that was conducted in 371 heavily treatment-experienced adults living with HIV-1 infection with multidrug resistance.
The firm already secured fast track and breakthrough therapy designations from the FDA. The company also intends to submit regulatory applications for fostemsavir to the European Medicines Agency and other global agencies in the coming months.
ViiV Healthcare CEO Deborah Waterhouse said: “Fostemsavir may provide an important treatment option for the group of people living with HIV who, for a variety of reasons, are not able to suppress their virus with other medicines and could be left with few or no treatments available to them.
“In keeping with our mission of leaving no person with HIV behind, we have overcome many barriers to bring this important new medicine to people living with HIV, including investing in what is a very complex manufacturing process.”
ViiV Healthcare is a specialist HIV company established by GSK and Pfizer.
In April this year, ViiV Healthcare submitted an NDA to the FDA for a two-drug regimen to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.