GSK 3684934 filed with FDA for HIV-1 infection.- ViiV Healthcare

ViiV Healthcare completed submission of a New Drug Application (NDA) to the FDA seeking approval of GSK 3684934 (fostemsavir) an investigational, first-in-class attachment inhibitor for the treatment of HIV-1 infection.

This submission is supported by the data from the pivotal phase III BRIGHTE study in heavily treatment-experienced people living with multidrug-resistant HIV. The 96-week results from the BRIGHTE study were most recently presented in July at the 10th International AIDS Society Conference on HIV Science. The primary endpoint analysis, based on the adjusted mean decline in HIV-1 RNA from Day 1 at Day 8 in the randomised cohort, demonstrated superiority of fostemsavir to placebo (0.79 vs. 0.17 log10 copies/mL decline, respectively; P<0.0001, intent-to-treat-exposed itt-e population. in the randomised cohort hiv-1 rna below 40 copies ml was achieved in 53 54 and 60 of subjects at weeks 24 48 and 96 respectively itt-e snapshot algorithm. mean changes in cd4 cell count from baseline continued to increase over time i.e. 90 cells mm3 at week 24 139 cells mm3 at week 48 and 205 cells mm3 at week 96. the most common adverse reactions incidence at least 5 all grades were nausea and diarrhoea. the proportion of participants who discontinued treatment with fostemsavir due to an adverse event was 7 at week 96 randomised: 5 and nonrandomised: 12.>

Comment: ViiV Healthcare plans to submit regulatory applications for fostemsavir to the European Medicines Agency and other global agencies in the coming months.