The US Food and Drug Administration (FDA) has approved approval for Eli Lilly and Company and Olcyiant of Incyte (baricitinib) for the treatment of Covid-19 in adult patients admitted to hospital.
Treatment is indicated for patients who require additional oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Discovered by Incyte and licensed to Lilly, Olumiant is an oral Janus kinase inhibitor (JAK).
The recommended dose is 4 mg Olumiant once daily for 14 days or until hospital discharge.
The latest approval is based on findings from two randomized, double-blind, placebo-controlled phase III clinical trials, ACTT-2 and COV-BARRIER.
No new safety signals potentially related to the use of Olumiant were found in these studies.
In November 2020, baricitinib was granted an Emergency Use Authorization (EUA) for use in the United States.
This EUA is applicable to hospitalized pediatric patients aged two to under 18 years who require different levels of oxygen support.
In addition, labeling for US FDA-approved therapy includes a warning in a box about the risk of mortality, serious infections, malignancies, thrombosis, and major adverse cardiovascular events.
Lilly Senior Vice President Patrick Johnson said: “Nearly one million people with Covid-19 have been treated with Olumiant (baricitinib) in approximately 15 countries around the world.
“Our full approval reflects both our confidence in Olumiant’s role in the treatment of these hospitalized patients and Lily’s tireless efforts to support the medical community and patients in the ongoing fight against Covid-19.
In July last year, the FDA expanded the EUA for baricitinib to treat Covid-19 with or without remdesivir.