FDA Expands Emergency Use Authorization for Baricitinib as Monotherapy in Hospitalized COVID-19 Patients

Source: Instant Pharma News

Today, the U.S. FDA revised the Emergency Use Authorization (EUA) for baricitinib (brand name Olumiant), now authorizing baricitinib for use alone in the treatment of hospitalized adult and pediatric COVID-19 patients aged 2 years and older who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Under the revised EUA, baricitinib is no longer required to be administered in combination with remdesivir (Veklury). The U.S. FDA has not formally approved baricitinib for the treatment of COVID-19.

This revision to the Emergency Use Authorization (EUA) for baricitinib is supported by clinical trial data in hospitalized patients with COVID-19, which demonstrated that baricitinib reduced the proportion of patients who died during the 28-day follow-up period compared to those receiving standard of care for COVID-19 alone. This clinical study did not require baricitinib to be used in combination with remdesivir, and the majority of patients in the study did not receive remdesivir.

The COV-BARRIER study, a randomized, double-blind, placebo-controlled clinical trial (NCT04421027) conducted in hospitalized adult patients diagnosed with COVID-19, compared baricitinib 4 mg once daily (n=764) with placebo (n=761). Patients were permitted to continue background standard-of-care therapy as defined by local guidelines, including antimalarials, antivirals, corticosteroids, and/or azithromycin. The most commonly administered treatments were corticosteroids (79% of patients, predominantly dexamethasone) and remdesivir (19% of patients). Specific study results indicated that the estimated proportion of patients who died or progressed to non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation was lower in the baricitinib group (27.8%) compared with the placebo group (30.5%); however, this effect did not reach statistical significance [odds ratio: 0.85 (95% CI 0.67, 1.08); p=0.180]. The proportion of patients who died by day 28 was 8.1% (62/764) for baricitinib versus 13.3% (101/761) for placebo [estimated difference in the probability of death at day 28 = 4.9% (95% CI: -8.0%, -1.9%); hazard ratio = 0.56 (95% CI: 0.41, 0.77)].

Although the revised EUA no longer requires baricitinib to be used in combination with remdesivir, the FDA authorization letter states that the COV-BARRIER trial supporting this revision did not raise concerns regarding the safety or efficacy of administering baricitinib in combination with remdesivir to hospitalized patients with COVID-19 who require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.

Remdesivir was previously approved by the FDA in October 2020 for the treatment of hospitalized adult and pediatric patients (aged 12 years and older, weighing at least 40 kg) with COVID-19. In November 2020, the FDA granted an Emergency Use Authorization (EUA) for the combination therapy of baricitinib and remdesivir for emergency use in hospitalized adult and pediatric patients (aged 2 years and older) with suspected or confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In May 2018, baricitinib, a Janus kinase (JAK) inhibitor from Eli Lilly and Company and Incyte, was approved by the FDA for the treatment of adult patients with moderate to severe rheumatoid arthritis who have not benefited from tumor necrosis factor (TNF) inhibitor therapy.

References:

[1] FDA authorizes baricitinib alone as treatment for COVID-19 . Retrieved 2021-07-29, from https://www.fda.gov/media/143822/download

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