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GSK, Vir's Intramuscularly-Administered Sotrovimab Shows Efficacy At Par With IV Route In COVID-19

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  • GSK
  • VIR
  • GlaxoSmithKline plc (NYSE: GSK) and Vir Biotechnology Inc (NASDAQ: VIR) have announced topline data from COMET-TAIL Phase 3 trial evaluating sotrovimab delivered via Intramuscular (IM) administration compared to IV administration in high-risk COVID-19 patients.

  • The trial achieved its primary endpoint, demonstrating that IM administration of sotrovimab was non-inferior to intravenous (IV) administration for the early treatment of mild-to-moderate COVID-19 up to seven days after symptom onset.

  • In the IM administration (500mg) arm, there was a 2.7% rate of progression to hospitalization for more than 24 hours or death through Day 29, compared to 1.3% in the IV administration arm (500mg).

  • The adjusted difference between the IM and IV arms of the trial was 1.07%.

  • GSK and Vir plan to progress regulatory submissions globally, including ongoing discussions with the FDA regarding the existing Emergency Use Authorization for sotrovimab.

  • Related Link: GSK - Vir Biotech's Sotrovimab Reduces Hospitalization, Risk Of Death In Adult COVID-19 Patients.

  • Price Action: VIR stock is up 1.41% at $33.52, and GSK shares are up 0.44% at $43.42 during the market session on the last check Friday.

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