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FDA Authorizes Anti-Inflammatory Drug Baricitinib For COVID-19 Treatment

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Key Takeaways

  • Anti-inflammatory drug baricitinib, which is currently approved for use for patients with rheumatoid arthritis, was granted emergency use authorization (EUA) from the FDA to treat COVID-19 in tandem with remdesivir.
  • A September study showed the anti-inflammatory drug baricitinib shortened hospital stays for COVID-19 patients by a day.


On Thursday, the Food and Drug Administration (FDA) issued an emergency use authorization to the anti-inflammatory drug baricitinib to treat COVID-19 in combination with anti-viral drug remdesivir. Remdesivir earned full FDA approval to treat hospitalized patients with COVID-19 in October.

This latest EUA applies to patients with either suspected or confirmed COVID-19, including:

  • Hospitalized adults
  • Children ages 2 and up who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)

While remdesivir needs to be administered intravenously, baricitinib is taken as an oral tablet. The latter is a janus kinase (JAK) inhibitor, a type of drug that blocks the response of enzymes which cause inflammation and autoimmunity.

Research published in September shows that together, baricitinib and remdesivir reduce the average hospital stay of patients by one day compared to treatment with remdesivir alone. The findings were announced by Eli Lilly and Company, who manufactures baricitinib, on September 14.

The 1,000-person study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), was conducted in the United States, Europe, Latin America, and Japan. It included patients who were hospitalized with COVID-19 who had at least one elevated marker of inflammation and evidence of pneumonia, but did not require mechanical ventilation when the study began. 

All participants in the study were given remdesivir, which is widely used in hospitalized COVID-19 patients, and some were also given four milligrams (mg) of baricitinib. Patients who were given baricitinib recovered enough to be released from the hospital, on average, one day faster than those who were only given remdesivir.

"There is an urgent need to identify COVID-19 treatments, and we will continue to work with NIAID to understand these data and next steps on baricitinib's role moving forward," Patrik Jonsson, Lilly senior vice president and president of Lilly Bio-Medicines, said in a press release.

What This Means For You

Thanks to this emergency use authorization, baricitinib could become another medication doctors use to help treat COVID-19 in hospitalized patients.

Baricitinib Basics

Baricitinib isn’t a new medication—the Eli Lilly drug is manufactured and marketed under the name Olumiant. It's approved in more than 70 countries, including the U.S., for treatment of moderate to severe rheumatoid arthritis.

Rheumatoid arthritis is an autoimmune disorder that causes the immune system to overreact and attack healthy joint tissues in the body, the National Institutes of Health (NIH) says. In COVID-19, a hyperactive immune response known as a cytokine storm can cause serious health complications for patients. “This drug could mitigate the cytokine storm,” Rajeev Fernando, MD, an infectious disease expert in New York, tells Verywell.

Given that baricitinib is already approved for rheumatoid arthritis treatment, “doctors can use it,” Jamie Alan, PhD, an assistant professor of pharmacology and toxicology at Michigan State University, tells Verywell. However, if a doctor were to currently use baricitinib to treat a COVID-19 patient, it would be considered an "off-label" use.

Baricitinib comes with a black box warning, per the FDA, about potential serious side effects, including the risk of infections like tuberculosis, and bacteria, fungal, and viral infections. Some patients treated with the drug have also developed lymphoma and potentially fatal blood clots.

Doctors are Already Using Anti-Inflammatories

Many hospitalized COVID-19 patients are currently treated with a combination of remdesivir and the corticosteroid dexamethasone, which is an anti-inflammatory medication, Watkins says. But it’s unclear how much anti-inflammatories help with COVID-19.

An anti-inflammatory medication like baricitinib blocks inflammatory pathways, Alan says, which could help prevent a cytokine storm. But Watkins says that the jury is still out on how much anti-inflammatory medications actually achieve when used to treat COVID-19.

“It is controversial because the human immune system is extremely complicated,” he says. “Recent studies that used other agents to block cytokine storm haven't found much clinical benefit.”

Faster Recovery Time Makes a Difference

Faster recovery time, even by just one day, can make a difference for COVID-19 patients. According to Richard Watkins, MD, an infectious disease physician and professor of internal medicine at the Northeast Ohio Medical University, patients being released a day early can expect reduced hospital expenses and fewer risks associated with being hospitalized, like hospital-acquired infections.

Alan says there are secondary factors that may also help patients. “If someone is close to losing their job because of being hospitalized and not having enough paid time off, then one day makes a huge difference,” she says.

Quicker recovery is also beneficial for an already overloaded healthcare system. “A bed will open up sooner,” Alan says.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.

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Article Sources
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  1. Food and Drug Administration. Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19. November 19, 2020

  2. Eli Lilly and Company. Baricitinib in COVID-19. September 14, 2020.

  3. Eli Lilly and Company. Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalized Patients with COVID-19 in NIAID-Sponsored ACTT-2 Trial. September 14, 2020.

  4. The National Institutes of Health. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Rheumatoid Arthritis. Last updated September 2019.

  5. Sinha P, Matthay MA, Calfee CS. Is a “Cytokine Storm” relevant to COVID-19? JAMA Intern Med. 2020;180(9):1152–1154. doi:10.1001/jamainternmed.2020.3313

  6. U.S. Food and Drug Administration. Olumiant Prescribing Information. June 2018.