ViiV Says Latest Data Back Two-Drug Approach, Plans Year-End Fostemsavir Filing
ViiV Healthcare research head tells Scrip she expects Dovato’s latest data presentation should boost the two-drug regimen’s uptake, and that the AIDS-fighter plans a US FDA filing of its investigational candidate fostemsavir before end-2019 following good Phase III BRIGHTE results.
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ViiV Healthcare has asked the European Medicines Agency to accelerate its review of fostemsavir when the company files for pan-EU market approval of the product.
Top-line results from the Phase III TANGO study suggests that switching to ViiV’s two-drug Dovato from a three-drug regimen does not affect the efficacy of treatment.