ViiV Seeks Speedy EMA Review For Last-Resort HIV Drug
US Filing For Fostemsavir Expected This Year
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.
You may also be interested in...
Janssen’s two investigational Ebola vaccines are among four new products recently granted fast-track review by the European Medicines Agency. GlaxoSmithKline and Viiv Healthcare are not disclosing the outcomes of accelerated assessment requests they have made.
The European Medicines Agency is this week deciding whether GlaxoSmithKline’s planned EU marketing application for its BCMA-targeting therapy merits an accelerated assessment.
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.