FDA issues Lilly’s arthritis drug baricitinib emergency approval for COVID-19 treatment

Eli Lilly and Co’s arthritis drug, baricitinib, was issued an emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19, when used in combination with remdesivir (Gilead Sciences Inc).

The baricitinib/remdesivir drug combination will be used in hospitalized adult and pediatric patients aged 2 and older who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Related: Remdesivir’s FDA approval to treat COVID-19 sets it ahead of treatment pack

A randomized, double-blind, placebo-controlled clinical trial (ACTT-2) was conducted by the National Institute of Allergy and Infectious Diseases (NIAID) to test the drug combination on hospitalized COVID-19 patients.¹

A reported 1,033 patients with moderate or severe COVID-19 participated in the study.¹ Patients were observed for 29 days, during which 515 patients received baricitinib plus remdesivir, and 518 patients received placebo plus remdesivir.

Related: Moderna’s COVID-19 vaccine candidate shows 94.5 percent efficacy in Phase 3 trial

Trial results

Results showed a reduction in median recovery time for patients treated with the baricitinib plus remdesivir versus those treated with remdesivir and a placebo.¹

In addition, the odds of a patient requiring a ventilator or dying at Day 29 was lower in the baricitinib plus remdesivir group versus the placebo plus remdesivir group. The odds of clinical improvement at Day 15 was also higher in the baricitinib plus remdesivir group versus the placebo plus remdesivir group.

Related: Pfizer’s COVID-19 vaccine shows more than 90 percent efficacy

Baricitinib, sold under the brand name Olumiant, is an FDA-approved Janus kinase (JAK) inhibitor drug that is taken orally for rheumatoid arthritis. It blocks the activity of one or more of a specific family of enzymes, which leads to reduced inflammation.

Safety and efficacy continues to be evaluated. Possible side effects of baricitinib in combination with remdesivir include serious infections, blood clots, changes in certain lab test results and allergic reactions.¹

Related: Is azithromycin cardiotoxic?

Baricitinib is not yet authorized or approved as a stand-alone treatment for the coronavirus.¹

Coronavirus update

In related news, the U.S. takes one step closer to its first COVID-19 vaccine with Pfizer and BioNTech filing for emergency vaccine use authorization. The two companies announced their mRNA vaccine candidate, BNT162b2, is 95 percent effective against the coronavirus and have officially filed for regulatory approval with the FDA.² If approved, authorization would enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.²

To learn more on COVID-19 vaccines in development, click here

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References

1. U.S. Food & Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19. Available at: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-combination-treatment-covid-19. Accessed 11/20/20.

2. Pfizer press release. Pfizer and BioNTech to submit emergency use authorization request today to the U.S. FDA for COVID-19 vaccine. Available at: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-submit-emergency-use-authorization. Accessed 11/20/20.