USA Food and Drug Administration revises authorisations for certain COVID-19 treatments

United States // 25 January, 2022

The US Food and Drug Administration (US FDA)  has published revised authorisations of two monoclonal antibody treatments in light of new data regarding the Omicron variant which is now dominant in the USA. Bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) are now limited to be used only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. Other treatments including Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir, remain available as they are expected to work against the omicron variant, and are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Healthcare providers should consult the NIH panel’s COVID-19 treatment guidelines and assess whether these treatments are right for their patients.

LATEST NEWS

  1. 1
  2. 2
  3. 3
  4. 4
  5. 5
  1. 1
  2. 2
  3. 3
  4. 4
  5. 5

Countering Misinformation & Disinformation: Practical Training for Organizations

Practical skills to detect, verify, and respond across an evolving information landscape