Table 2. Therapies Approved by the Main Regulatory Agencies Worldwide for Treatment of COVID-19 Patientsa.
| approval
by regulatory agencies |
||||||||
|---|---|---|---|---|---|---|---|---|
| drug | category | FDA | EMA | PMDA | ANVISA | indication | route of administration/therapeutic scheme | benefits |
| Antiviral Therapies | ||||||||
| remdesivir (Veklury) | viral RdRp inhibitor | approved (2020/10/22) | conditional marketing authorization (2020/07/03) | special approval for emergency (2020/05/07) | approved (2021/03/12) | 12-year-old or older COVID-19 patients that are hospitalized | intravenous infusion/attack dose of 200 mg on day 1 followed by 100 mg once daily | improves rates of recovery and discharge and reduces the development of serious adverse events461 |
| casirivimab and imdevimab (REGEN-COV or Ronapreve) | recombinant human IgG1 monoclonal antibodies against SARS-CoV-2 spike protein | EUA (2020/11/21) | marketing authorization (2021/11/12) | special approval for emergency (2021/07/19) | approved for emergency use (2021/04/20) | 12-year-old or older COVID-19 patients with mild to moderate disease who are at high risk for progression to severe COVID-19 or as postexposure prophylaxis | intravenous infusion or subcutaneous injection/single dose of 600 mg of casirivimab and 600 mg of imdevimab | reduces disease-related hospitalizations or deaths when administrated postinfection474 |
| reduces the risk of developing symptomatic or asymptomatic COVID-19 when administred as postexposure prophylaxis477 | ||||||||
| bamlanivimab and etesevimab | human IgG1 monoclonal antibodies against SARS-CoV-2 spike protein | EUA (2021/02/09) | none (recommended) | none | approved for emergency use (2021/05/13) | 12-year-old or older COVID-19 patients with mild to moderate disease who are at high risk for progression to severe COVID-19 or as postexposure prophylaxis | intravenous infusion/single dose of 700 mg of bamlanivimab and 1400 mg of etesevimab | reduces the number of related hospitalizations or deaths and improves viral load reduction from baseline484 |
| sotrovimab | recombinant human IgG1κ monoclonal antibody against SARS-CoV-2 spike protein | EUA (2021/05/26) | none (recommended) | special approval for emergency (2021/09/27) | approved for emergency use (2021/09/08) | 12-year-old or older COVID-19 patients with mild to moderate disease who are at high risk for progression to severe COVID-19 | intravenous infusion/single dose of 500 mg | reduces the risk of hospitalizations or deaths of any cause494 |
| regdanvimab (Regkirona) | human IgG monoclonal antibody anti- SARS-CoV-2 spike protein | none | marketing authorization (2021/11/12) | none | approved for emergency use (2021/08/11) | adult COVID-19 patients with mild to moderate disease who are at high risk for progression to severe COVID-19 | intravenous infusion/single dose of 40 mg/kg | accelerates viral clearance and clinical recovery498 |
| baricitinib (Olumiant) | inhibitor of JAK1/JAK2 (anti-inflammatory effect) and AAK1 and GAK (endocytosis inhibitor) | EUA (2020/02/04) | none | special approval for emergency (2021/04/23) | approved for emergency use (2021/09/17) | hospitalized COVID-19 patients in need of supplemental oxygen | oral/4 mg per day for 14 days or until discharge | reduces mortality rates, intensive care unit admissions, requirement for invasive mechanical ventilation, and risk of serious adverse events508 |
| Immunomodulatory Therapies | ||||||||
| tocilizumab (Actemra) | recombinant humanized monoclonal antibody against IL-6 receptor | EUA (2021/06/24) | none | none | none | hospitalized 2-year-old or older COVID-19 patients who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation | intravenous infusion/single dose of 8 mg/kg (patients with weight ≥ 30 kg) or 12 mg/kg (patients with weight < 30 kg) | reduces risk of needing mechanical ventilation and poor outcome520 |
a
Legend: FDA, U.S. Food and Drug Administration; EMA, European Medicines Agency (European Union); PMDA, Pharmaceuticals and Medical Devices Agency (Japan); ANVISA, Agência Nacional de Vigilância Sanitária (Brazil); EUA, Emergency Use Authorization; RdRp, RNA-dependent RNA polymerase; IgG, immunoglobulin G; JAK, Janus kinase; AAK1, AP2-associated kinase 1; GAK, cyclin G-associated kinase; IL-6, interleukin 6.