- 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.
