Posted by Michael Wonder on 13 Dec 2020
ViiV Healthcare announces positive CHMP opinion for Rukobia (fostemsavir), a first-in-class attachment inhibitor for the treatment of adults with multidrug-resistant HIV with few treatment options available
11 December 2020 - Findings from pivotal phase III BRIGHTE study demonstrated that the majority (60%) of heavily treatment-experienced adults randomised to receive fostemsavir with an optimised background therapy achieved and maintained viral suppression at 96 weeks.
ViiV Healthcare today announced that the EMA's CHMP issued a positive opinion recommending approval of Rukobia (fostemsavir) 600 mg extended release tablets, a novel attachment inhibitor for the treatment of HIV-1 infection.
Fostemsavir, in combination with other antiretrovirals, is indicated for the treatment of adults with multi-drug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.
