Get all your news in one place.
100’s of premium titles.
One app.
Start reading
Benzinga
Benzinga
Technology
Vandana Singh

FDA Says Current Dose Of GSK-Vir's COVID-19 Therapy Unlikely To Work Against Omicron Subvariant

  • 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.
Sign up to read this article
Read news from 100’s of titles, curated specifically for you.
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
Fourteen days free
Download the app
One app. One membership.
100+ trusted global sources.