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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