Scroll to Top

Updates in the Treatment and Prevention of COVID-19

Emergency use authorization for casirivimab/imdevimab in patients with mild-to-moderate COVID-19

The combination of the monoclonal antibodies casirivimab and imdevimab (previously known as REGN-COV2) has been authorized for emergency use for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (≥12 years of age and ≥40 kg) who are at high risk for progressing to severe COVID-19 or hospitalization.1

Interim results from 275 nonhospitalized patients in a placebo-controlled trial of casirivimab plus imdevimab found that the combination therapy reduced viral load, with a greater effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline. Patients who received casirivimab/imdevimab required fewer medical visits for COVID-19 than patients who received placebo (3% vs 6%, respectively). Among patients who were serum antibody-negative at baseline, 15% in the placebo group and 6% in the treatment group required COVID-19-related medical care.2

Baricitinib in combination with remdesivir authorized for emergency use in hospitalized patients

Baricitinib, in combination with remdesivir, is authorized for emergency use in adult and pediatric patients ≥2 years of age hospitalized for COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).3

A recent trial of 1033 patients hospitalized for COVID-19 found that baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time (7 days vs 8 days, respectively; P= .03). Patients receiving high-flow oxygen or noninvasive ventilation at enrollment had a time to recovery of 10 days with combination therapy and 18 days with the control (rate ratio for recovery, 1.51). The addition of baricitinib to remdesivir was associated with 30% higher odds of improvement in clinical status at day 15 compared with remdesivir alone.4

References

  1. Emergency use authorization (EUA) of casirivimab and imdevimab. Available at www.fda.gov/media/143892/download. Accessed 12/23/2020.
  2. Weinreich DM, Sivapalasingam S, Norton T, et al. REGN-COV2, a neutralizing antibody cocktail, in outpatients with Covid-19. N Engl J Med. 2020;Dec 17:Epub ahead of print. Available at www.nejm.org/doi/full/10.1056/NEJMoa2035002. Accessed 12/23/2020.
  3. Emergency use authorization (EUA) of baricitinib. Available at www.fda.gov/media/143823/download. Accessed 12/23/2020.
  4. Kalil AC, Patterson TF, Mehta AK, et al. Baricitinib plus remdesivir for hospitalized adults with Covid-19. N Engl J Med. 2020;Dec 11:Epub ahead of print. Available at www.nejm.org/doi/full/10.1056/NEJMoa2031994. Accessed 12/23/2020.