Rukobia (Fostemsavir) from ViiV Healthcare gots the USFDA approval for HIV in Patients with Limited Treatment Options
Rukobia (Fostemsavir) got the approval based on the P-III BRIGHTE study assessing Rukobia (600mg, ER) + OBT in 371 HTE adults living with multidrug-resistant HIV. Participants were enrolled in either a randomized or nonrandomized cohort
In the randomized cohort, 60% adults achieved undetectable HIV viral load and clinically meaningful improvements to CD4 + T-cell count @ 96wks., HIV-1 RNA <40 copies / mL @ 24 & 96wks. (53% & 60%); changes in CD4 + cell count (90 & 205 cells / mm3) respectively
In the nonrandomized cohort, 37% achieved HIV-1 RNA <40 copies / mL @ 24 & 96wks .; HIV-1 RNA <200 copies / mL (42% & 39%); mean changes in CD4 + cell count (41 & 119 cells / mm3) respectively. Fostemsavir is a first-in-class HIV-1 attachment inhibitor, currently under EMA's review with additional submissions to regulatory authorities anticipated in 2020 & 2021
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