ViiV Healthcare’s Rukobia has received a marketing authorisation in Europe for the treatment of adults with multidrug-resistant HIV-1 infection.
The European Commission (EC) has authorised ViiV Healthcare’s Rukobia (fostemsavir) 600mg extended-release tablets for use in combination with other antiretroviral (ARV) therapies for the treatment of adults with multidrug-resistant HIV-1 infection, for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
Despite the many HIV drugs on the market, some patients still can’t be successfully treated due to resistance. Now, they have a new option.
LONDON--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets. Rukobia is a novel attachment inhibitor for the treatment of HIV-1 infection indicated for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection, who are failing their current ARV regimen due to resistance, intolerance or safety considerations.
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (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 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.