Benzinga | Jun 21, 2021 11:41AM EDT

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.