The federal agency authorized the therapy as a standalone treatment via a revised EUA in July of last year.
The US Food and Drug Administration (FDA) has approved baricitinib (Olumiant) for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The new indication follows the original Emergency Use Authorization (EUA), which was granted in November 2020 for baricitinib in combination with remdesivir in hospitalized adults and pediatric patients.
“Today’s full approval reflects our confidence in the medicine’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,” Patrik Jonsson, Lilly senior vice president, president of Lilly Immunology and Lilly USA, and chief customer officer, said in a statement.
The FDA authorized baricitinib as a standalone treatment via a revised EUA in July 2021. The treatment remains under EUA for hospitalized patients ages 2 to less than 18 years of age who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO, according to an FDA statement.
The approval was issued based on 2 randomized, double-blind, placebo-controlled phase 3 studies of approximately 2650 patients hospitalized with COVID-19 requiring various degrees of oxygen support.
In the COV-BARRIER study (NCT04421027), the therapy did not meet its primary end point, but did show a statistically significant reduction in mortality (38%) compared with standard of care alone. The primary end point was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including ECMO or death by Day 28.
“Baricitinib-treated patients were 2.7 percent less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death, a difference that was not statistically significant (odds ratio [OR]: 0.85; 95% CI 0.67, 1.08; P = .1800),” Lilly and Incyte reported in April 2021.
The study included 1525 patients and began in June of 2020. All participants were treated with standard of care, which could have included corticosteroids, antimalarials, antivirals, and/or azithromycin. They were randomized 1:1 to receive either 4 mg of baricitinib or a placebo for up to 14 days or until discharge from the hospital.
The NIAID investigators previously reported that baricitinib plus remdesivir achieved the ACTT-2 primary endpoint of median time to recovery: a one-day, or 12.5% overall, improvement versus lone remdesivir (8 vs 7; incidence rate ratio [IRR], 1.16; 95% CI, 1.01-1.32; P = .04). Recovery was defined hospital discharge or removal from supplemental oxygen during hospital care at day 29.
Additionally results from the NIAID's ACTT-2 study showed that there was a significant reduction in the proportion of patients progressing to noninvasive ventilation, invasive mechanical ventilation or death. A numerical decrease in mortality risk through Day 29 was also observed in patients treated with baricitinib plus remdesivir.
Investigators observed a 35% decrease in death among patients treated with baricitinib plus remdesivir (5.1%) versus lone remdesivir (7.8%) at day 29 (hazard ratio [HR], 0.65; 95% CI, 0.39-1.08; P = .09). Patients receiving oxygen at baseline reported more pronounced reductions in mortality: group 5 and group 6 patients reported 60% and 43% reduced mortality risks, respectively.
During the study, investigators reported no new safety signals among patients with COVID-19 to have received baricitinib.