FDA OKs emergency use of baricitinib alone for COVID-19

The FDA has authorized emergency use of baricitinib alone for the treatment of patients aged 2 years and older who are hospitalized with COVID-19.

The authorization applies to infected patients who require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation, according to a press release from the FDA. This is an update to the agency’s previous emergency use authorization, which mandated that baricitinib (Olumiant, Eli Lilly & Co.) be administered in conjunction with remdesivir (Veklury; Gilead Sciences).

“Baricitinib in combination with remdesivir has already provided many people with a treatment option that could help prevent progression to ventilation or death and increase recovery speed for certain hospitalized patients with COVID-19 under its currently authorized use,” Ilya Yuffa, senior vice president of Eli Lilly & Co. and president of Lilly BioMedicines, said in a press release. “[This] FDA action provides physicians additional treatment regimen options for baricitinib to continue to meet the urgent medical needs posed by this pandemic. Based on the increasing body of evidence, we are confident in the potential of baricitinib as an important treatment for the hospitalized COVID-19 patient population requiring supplemental oxygen.”

The FDA’s decision is based on data from the phase 3 COV-BARRIER study, a randomized, double-blind, placebo-controlled study of hospitalized patients. Researchers compared baricitinib 4 mg once daily plus standard care against placebo plus standard care. They found that patients on baricitinib were less likely to progress to ventilation or death (OR = 0.85; 95% CI, 0.67-1.08), according to a press release from the manufacturer. The addition of baricitinib to standard care was associated with a 39% reduced risk for death at day 28.

“Recent clinical data have helped improve our understanding of the potential role of baricitinib in the treatment of certain hospitalized patients with COVID-19 and the broadened emergency use authorization represents a critical step in fighting the pandemic,” E. Wesley Ely, MD, MPH, professor of medicine and codirector of the Critical Illness, Brain Dysfunction and Survivorship Center at Vanderbilt University Medical Center and co-principal investigator of COV-BARRIER, said in the release.

References:

Eli Lilly. FDA broadens existing emergency use of Lilly and Incyte’s baricitinib in patients hospitalized with COVID-19 requiring oxygen. https://investor.lilly.com/news-releases/news-release-details/fda-broadens-existing-emergency-use-lilly-and-incytes. Accessed July 29, 2021.

FDA. FDA authorizes baricitinib alone as treatment for COVID-19. https://content.govdelivery.com/accounts/USFDA/bulletins/2ea74e3. Accessed July 29, 2021.