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ViiV Healthcare announces positive CHMP opinion for Rukobia (fostemsavir), a first-in-class attachment inhibitor for the treatment of adults with mult
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ViiV Healthcare meldet positive Stellungnahme des Ausschusses für Humanarzneimittel zu Rukobia (Fostemsavir), dem ersten Attachment-Inhibitor seiner Wirkstoffklasse zur Behandlung von Erwachsenen mit multiresistenter HIV-1-Infektion bei wenigen
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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
Fostemsavir addresses a critical unmet need in HIV care for those with little to no treatment options left
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ( GSK ), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the European Medicines Agency s (EMA) Committee for Medicinal Products for Human Use (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 multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppre