FDA Approves Lilly and Incyte's Olumiant For Hospitalized COVID-19 Patients
Olumiant oral drug has been approved by FDA to treat hospitalized COVID-19 patients.
The U.S. Food and Drug Administration (FDA) has given approval for the commercialization of Eli Lilly and Company and Incyte’s Olumiant (baricitinib), setting a precedent for COVID-19 treatments. The treatment is once-daily and orally administered. Before the approval, Olumiant was used to treat COVID-19 through the FDA’s Emergency Use Authorization (EUA).
Olumiant is the first FDA approved Janus kinase (JAK) inhibitor, intended as a treatment for hospitalized COVID-19 patients that require supplemental oxygen, extracorporeal membrane oxygen (ECMO), or the use of a ventilator. The FDA determined that the safety and efficacy of Olumiant were sufficiently supported through the Phase-III Adaptive COVID-19 Treatment Trial 2 (ACTT-2) and COV-Barrier clinical trials. The former was sponsored by the National Institute of Allergy and Infectious Diseases, while the COV-Barrier trial was sponsored by Lilly.
Patrik Jonsson, Lilly senior vice president, president of Lilly Immunology and Lilly USA, and chief customer officer commented on the milestone accomplishment.
“Nearly one million people with COVID-19 have been treated with Olumiant (baricitinib) in approximately 15 countries worldwide. Today's full approval reflects both our confidence in Olumiant's role in treating these hospitalized patients and Lilly's tireless efforts to support the medical community and patients in the ongoing fight against COVID-19."
JAK small molecule inhibitors manipulate the JAK-STAT signaling. The JAK-STAT pathway’s role in the inflammatory response is an ideal target for the reduction of inflammatory symptoms. COVID-19 infection severity is characterized by the degree of inflammatory response.
How does Olumiant Work?
These inflammatory responses cause cytokine secretion to influence cell response to the inflammation. Olumiant interrupts the communication of an inflammatory response by interfering with cytokine activity.
The ACTT-2 principal investigator and Professor of Medicine at the University of Nebraska Medical Center, Andre Kalil, M.D., M.P.H. explained the significance of the new COVID-19 treatment option.
"More than two years into the pandemic, COVID-19 is still hospitalizing many people and burdening our healthcare system. I'm grateful to have Olumiant as a treatment option for those who require various degrees of respiratory support, from supplemental oxygen to mechanical ventilation or ECMO," he said. "I'm encouraged by the FDA's full approval of Olumiant for the treatment of these patients based on results from the rigorous, placebo-controlled, double-blind, randomized trials. While there are therapies currently available, there is still an urgent need for more options to help improve outcomes for patients hospitalized due to COVID-19."
The road to FDA approval of Olumiant has been long and winding, beginning with a 2009 agreement between Lilly and Incyte to pursue indications of inflammatory and autoimmune diseases.
Olumiant has additional approvals, including for the indication of moderate to severe active rheumatoid arthritis. A Phase-III clinical trial investigating the JAK-inhibitor to treat patients with Lupus was suspended after a review of data from the preceding Phase-II trials. A supplemental New Drug Application (sNDA) was filed for Olumiant as a treatment for adult cases of moderate to severe atopic dermatitis but was rejected due to target population misalignment. In Japan and the European Union, Olumiant is approved for the treatment of atopic dermatitis.