Sign in Subscribe
COVID-19

Revocation of Emergency Use Authorization for Remdesivir to Treat COVID-19

Strategic Insights

— 1 min read

The US Food and Drug Administration (FDA) has revoked the Emergency Use Authorization (EUA) for Gilead Sciences' remdesivir, marketed as VEKLURY, for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients. The revocation, effective April 25, 2022, was made possible by the approval of a supplemental new drug application (NDA) for VEKLURY, which expanded the approved indication to cover the authorized population. The FDA concluded that VEKLURY approved under NDA 214787 is an adequate, approved, and available alternative to the VEKLURY available for emergency use.

Key Takeaways:

  • The Emergency Use Authorization (EUA) for VEKLURY was revoked on April 25, 2022, by the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • The revocation was made possible by the approval of a supplemental NDA for VEKLURY, which expanded the approved indication to cover the authorized population.
  • The FDA concluded that VEKLURY approved under NDA 214787 is an adequate, approved, and available alternative to the VEKLURY available for emergency use.
  • The EUA was issued on May 1, 2020, and was subject to several amendments, with the final amendment made available on January 21, 2022.
  • The revocation was announced by the FDA on July 19, 2022, and is effective as of April 25, 2022.
  • The revocation is in line with section 564(g) of the FD&C Act, which allows the Secretary of HHS to revoke an EUA if the criteria for issuance are no longer met.

Statistics:

  • The EUA was issued on May 1, 2020, and was revoked on April 25, 2022 (365 days).
  • The revocation was made possible by the approval of a supplemental NDA for VEKLURY, which expanded the approved indication to cover the authorized population.
  • The FDA concluded that VEKLURY approved under NDA 214787 is an adequate, approved, and available alternative to the VEKLURY available for emergency use, with an approved indication for the treatment of COVID-19 in adults and pediatric patients.
  • The EUA was subject to several amendments, with the final amendment made available on January 21, 2022.

Sources:

  • US Food and Drug Administration. "Revocation of Emergency Use of a Drug During the COVID-19 Pandemic; Availability." Federal Register, July 26, 2022.
  • Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3)
  • Project BioShield Act of 2004 (Pub. L. 108-276)
  • Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)

Read more