GSK and VIR Report EUA Submission to the US FDA for VIR-7831 to Treat COVID-19

March 29, 2021 Auto Bot Biotech, EUA, FDA, GSK, regulatory, reports, Submission, Vir, VIR-7831 0

Shots:

  • The EUA submission is based on an interim analysis of the P-III COMET-ICE study assessing VIR-7831 vs PBO for the early treatment of COVID-19 in 583 adults at high risk of hospitalization
  • The study demonstrated an 85% reduction in hospitalization. Due to evidence of profound efficacy, IDMC recommended stopping the trial for further enrollment
  • Preclinical data of VIR-7831 suggested that the mAB maintains its activity against emerging variants. Additionally, the companies will continue discussions with the EMA and other global regulators to make VIR-7831 available to patients with COVID-19 asap

Click here ­to­ read full press release/ article | Ref: GSK | Image: Financial Times

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