Posted by Michael Wonder on 11 Jan 2020
ViiV Healthcare submits regulatory application to the European Medicines Agency for fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV in adults with few treatment options available
10 January 2020 - ViiV Healthcare with Pfizer and Shionogi, today announced the submission of a marketing authorisation application to the EMA seeking approval of fostemsavir, an investigational, first-in-class attachment inhibitor for the treatment of HIV-1 infection.
This application seeks approval of fostemsavir, used in combination with other antiretrovirals, for the treatment of adults with multi-drug 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 has granted an accelerated assessment for the fostemsavir application.
This submission is supported by data from the pivotal phase III BRIGHTE study in heavily treatment-experienced people living with multi-drug-resistant HIV.
