FDA Grants EUA to Baricitinib-Remdesivir Combination for COVID-19 Treatment

The FDA has granted an Emergency Use Authorization (EUA) to Eli Lilly and Company and Incyte for baricitinib in combination with remdesivir in hospitalized patients with suspected or confirmed coronavirus disease 2019 (COVID-19) infection.

The drug combination is to be used in both adult and pediatric patients with COVID-19 requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.

Related: Baricitinib Plus Remdesivir Improves Recovery Time for Hospitalized COVID-19

Baricitinib is an oral JAK inhibitor approved in the United States for the treatment of moderate-to-severe rheumatoid arthritis (RA). Remdesivir is an antiviral medication reported to improve recovery time in adults hospitalized with COVID-19; it was approved by the FDA to treat COVID-19 late last month, which made it the first FDA-approved treatment for the virus.

Related: FDA Approves Remdesivir for Treatment of COVID-19

Authorization of the combined drug indication was based on Lilly’s phase 3 Adaptive COVID-19 Treatment Trial (ACTT-2) conducted by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH).

The randomized, double-blind, placebo-controlled study findings recommend administering baricitinib in 4-mg doses once daily for 14 days or until hospital discharge.

The ACTT-2 trial, of which the FDA based its authorization, found that COVID-19 patients treated with baricitinib in combination with remdesivir experienced significant reductions in median recovery time from 8 to 7 days (12.5% improvement) compared with remdesivir alone. Patients receiving baricitinib with remdesivir were also more likely to demonstrate better clinical status at day 15 compared with patients receiving remdesivir only.

NIAID will publish its full analysis of the ACTT-2 trial soon, according the news release.

"The results of ACTT-2 provide physicians and the medical community much-needed insights and randomized placebo-controlled evidence supporting the use of baricitinib in combination with remdesivir for the treatment of hospitalized patients with COVID-19; also importantly, the progression to ventilation or death was significantly reduced with the baricitinib-remdesivir combination," said Andre Kalil, MD, professor at the University of Nebraska Medical Center and a principal investigator of the ACTT studies.

"Few treatment options have received an EUA to treat COVID-19 so the authorization of baricitinib is an important step that will give healthcare providers another clinical tool to help patients with advanced disease," Kalil added.

Baricitinib is not currently approved by the FDA to treat COVID-19; authorization is temporary and does not replace the agency’s formal review process.

Reference:

1. Baricitinib Receives Emergency Use Authorization from the FDA for the Treatment of Hospitalized Patients with COVID-19. News Release. Lilly; November 19, 2020. Accessed November 20, 2020. https://investor.lilly.com/news-releases/news-release-details/baricitinib-receives-emergency-use-authorization-fda-treatment.