![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » EMA Reviews GSK’s and Vir’s VIR-7831 for COVID-19
EMA Reviews GSK’s and Vir’s VIR-7831 for COVID-19
![EMA logo European Medicines Agency logo](https://www.fdanews.com/ext/resources/test/Drug-Images3/EMAlogo.jpg?t=1628546093&width=430)
April 16, 2021
The European Medicines Agency (EMA) has begun a review of GlaxoSmithKline (GSK)’s and Vir Biotechnology’s monoclonal antibody VIR-7831 as a treatment for COVID-19 patients.
The EMA is assessing data from a phase 3 study showing the monoclonal antibody reduced the risk of hospitalization or death in COVID-19 patients by 85 percent vs. placebo.
The agency said it is conducting the review “to support national authorities who may decide on the use of this medicine for COVID-19,” ahead of a more comprehensive review when the companies apply for marketing authorization.
GSK and Vir filed for FDA Emergency Use Authorization for VIR-7831 in late March based on the strong efficacy seen in their phase 3 study.
Upcoming Events
-
21Oct