- GlaxoSmithKline plc GSK and Vir Biotechnology Inc VIR have announced final, confirmatory results from the Phase 3 COMET-ICE evaluating sotrovimab in high-risk adult outpatients with mild-to-moderate COVID-19.
- Data demonstrated a 79% reduction in hospitalization for more than 24 hours or death compared with placebo after 29 days.
- The most common adverse events observed in the sotrovimab treatment group were rash (1%) and diarrhea (2%), all mild or moderate.
- No other treatment-emergent adverse events were reported at a higher rate with sotrovimab compared to placebo.
- The U.S. National Institutes of Health has added sotrovimab to its COVID-19 treatment guidelines.
- The companies will manufacture approximately two million doses to support emergency supply in the first year following FDA Emergency Use Authorization, with about 450,000 doses on hand.
- FDA marketing application submission is expected in the second half of 2021.
- Further research has been initiated to evaluate intramuscular administration of sotrovimab for the early treatment of mild-to-moderate COVID-19 in high-risk patients.
- Price Action: GSK shares are up 0.04% at $39.86, and VIR shares up 3.41% at $47.73 during the market trading session on the last check Monday.
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