Recently, Business Insider reported on published, peer-reviewed results following the Adaptive COVID-19 Treatment Trial (ACTT-2). The Phase 3 clinical trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), centered around evaluating baricitinib for moderate-to-severe cases of COVID-19. As many of us know, COVID-19 is a novel coronavirus attributed to millions of cases – and deaths – across the globe. While many cases are mild, some turn severe, resulting in hospitalization and respiratory support.

Now, biopharmaceutical company Incyte, and global healthcare leader Eli Lilly and Company (“Lilly”), share that this published data in The New England Journal of Medicine helped support emergency use authorization (EUA) for baricitinib, in conjunction with remdesivir, for hospitalized patients with COVID-19 who require extra respiratory support.

Baricitinib

First discovered by Incyte, and later licensed for Lilly use, baricitinib is an orally-administered Janus kinase (JAK) inhibitor. Normally, JAK plays a role in cytokine-related inflammation. The “cytokine storm” has been associated with severe cases of COVID-19. By blocking JAK, baricitinib reduces inflammation and improves patient respiratory-related outcomes. Despite its EUA, baricitinib is not yet approved for the treatment of COVID-19. Additionally, there is still limited safety and efficacy data available in this realm. In prior uses, baricitinib treated rheumatoid arthritis (RA) and severe atopic dermatitis. Under the EUA, baricitinib can be used alongside remdesivir to treat patients ages 2+.

Emergency Use Authorization (EUA)

According to the FDA, emergency use authorization (EUA) works by allowing:

unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by [chemical, biological, radiological, and nuclear] threat agents when there are no adequate, approved, and available alternatives.

In part, bariticinib was approved for EUA following results from the Phase 3 ACTT-2 clinical trial. During the trial, patients were either treated with a baricitinib-remdesivir combination or a placebo. Ultimately, this combination reduced the need for ventilation or additional respiratory support, helped patients to recover more quickly, and reduced mortality rates in comparison to patients just receiving oxygen.

Baricitinib Safety Information

Currently, there is only a small amount of clinical data available. However, some considerations include:

• Adverse reactions include infections, pulmonary embolism, and other forms of venous thrombosis.
• Patients with tuberculosis, who are on dialysis, or who have severe kidney or liver problems should not take this drug.
• Baricitinib should only be used during pregnancy if a doctor determines that there is minimal risk to the parent and child.
• Doctors should closely monitor patient laboratory values while using this treatment.