ViiV Healthcare has recently completed its New Drug Application (NDA) submission to the 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 antiviral agents in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection who are unable to form a suppressive regiment due to resistance, intolerance or safety considerations.
“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,” said Deborah Waterhouse, CEO of ViiV Healthcare.
The NDA submission is supported by the data from the pivotal phase III BRIGHTE study in heavily treatment-experienced people living with multidrug-resistant HIV.
Fostemsavir has been granted FDA Fast Track and Breakthrough Therapy Designations.
ViiV Healthcare said it plans to submit regulatory applications for fostemsavir to the European Medicines Agency and other global agencies in the coming months.