GSK - Vir Biotech's Sotrovimab Reduces Hospitalization, Risk Of Death In Adult COVID-19 Patients
GlaxoSmithKline plc (NYSE: GSK) and Vir Biotechnology Inc (NASDAQ: 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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