ViiV Healthcare is seeking approval from the European Medicines Agency (EMA) for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV-1 infection.
The application seeks approval of fostemsavir, used in combination with other antiretrovirals, for the treatment of adults with multidrug-resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive antiviral regimen due to resistance, intolerance or safety considerations.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has granted an accelerated assessment for the fostemsavir a marketing authorisation application (MAA).
The submission is supported by data from the pivotal phase III BRIGHTE study in heavily treatment-experienced people living with multidrug-resistant HIV.
This application follows the recent submission of a New Drug Application for fostemsavir to the FDA in December 2019.
In the US, fostemsavir has been granted FDA Fast Track and Breakthrough Therapy Designations. ViiV Healthcare plans to submit regulatory applications for fostemsavir to other global agencies in the coming months.