- The FDA said that the currently authorized 500mg dose of GlaxoSmithKline Plc (NYSE:GSK) and Vir Biotechnology Inc's (NASDAQ:VIR) COVID-19 antibody therapy is unlikely to be effective against the omicron BA.2 variant.
- The agency updated its website to exclude sotrovimab use in geographic regions where the infection is likely caused by the omicron BA.2 variant.
- GSK and Vir said they are preparing a data package to support a higher dose for sotrovimab for the BA.2 subvariant.
- Related: AstraZeneca, GSK's COVID-19 Therapies Lose Efficacy Against Omicron's Subvariants.
- The FDA also said Eli Lilly And Co's (NYSE:LLY) newly authorized antibody therapy bebtelovimab, along with Merck & Co Inc (NYSE:MRK) and Pfizer Inc's (NYSE:PFE) antiviral pills and Gilead Sciences Inc's (NASDAQ:GILD) remdesivir, is expected to be effective against the BA.2 variant.
- According to an SEC filing, Vir Biotech still expects to recognize approximately $1.1 billion of sotrovimab collaboration revenues when sotrovimab doses are delivered in 1H of 2022.
- The companies still expect to manufacture approximately 2 million doses in 1H of 2022 and additional doses in 2H of 2022.
- GSK and Vir Biotech plan to submit an FDA marketing application for sotrovimab in 2H of 2022.
- The companies expect to commence two Phase 3 trials in Q2 of 2022 for sotrovimab in uninfected immunocompromised patients to prevent symptomatic COVID-19 infection.
- Price Action: GSK shares are up 0.20% at $43.36, VIR stock is down 3.90% at $20.96 during the market session on the last check Monday.
Get all your news in one place.
100’s of premium titles.
One app.
Start reading
One app.
Get all your news in one place.
100’s of premium titles. One news app.
FDA Says Current Dose Of GSK-Vir's COVID-19 Therapy Unlikely To Work Against Omicron Subvariant
Sign up to read this article
Read news from 100’s of titles, curated specifically for you.
Already a member?
Sign in here
Top stories on inkl right now
One subscription that gives you access to news from hundreds of sites
Already a member?
Sign in here
Related Stories
Top stories on inkl right now
One subscription that gives you access to news from hundreds of sites
Already a member?
Sign in here
Our Picks