GlaxoSmithKline (LSE/NYSE:GSK) and its partner Vir Biotechnology (NSDQ:VIR) have received marketing authorization from the European Commission for the dual-action monoclonal antibody Xevudy (sotrovimab).
The marketing authorization covers individuals 12 and older who weigh at least 40 kg who do not need supplemental oxygen. It also requires that such individuals have a heightened risk of developing severe COVID-19.
This summer, GSK and VIR had reached a joint procurement agreement with the EC involving 220,000 doses of the drug.
“With today’s marketing authorization we are now able to expand access, and we are discussing with governments how we can bring sotrovimab to more patients,” said Dr. Hal Barron, chief scientific officer and president R&D of GSK, in a statement.
The two companies also have revealed that preclinical data suggest that sotrovimab retains activity against the Omicron variant, which threatens to become the dominant form of SARS-CoV-2 in early 2022.
A preprint study details the antibody’s performance against a variety of SARS-CoV-2 variants, including Omicron, Delta, Delta Plus and Mu.
To date, sotrovimab has been the subject of more than one dozen studies.
Sotrovimab was formerly known as VIR-7831.
The drug is also available in the U.S. under emergency use authorization.