SGIOY - European advisory group backs ViiV's Rukobia in HIV-1 infection

The European Medicines Agency's advisory group CHMP has issued a positive opinion recommending approval of ViiV Healthcare's Rukobia (fostemsavir) 600 mg extended-release tablets for the treatment of HIV-1 infection.Final marketing authorization from the European Commission is anticipated in the coming months. Fostemsavir was approved by the US FDA on July 2, 2020 and further regulatory applications have been submitted worldwide.ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (GSK), Pfizer (PFE) and Shionogi (SGIOY).Fostemsavir, in combination with other antiretrovirals, is indicated 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.

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European advisory group backs ViiV's Rukobia in HIV-1 infection