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 GSK and Vir Biotechnology Inc's 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 LLY newly authorized antibody therapy bebtelovimab, along with Merck & Co Inc MRK and Pfizer Inc's PFE antiviral pills and Gilead Sciences Inc's 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.
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