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New drug to help treat hospitalized COVID-19 patients receives emergency use authorization

Lilly purchases gene therapy company
Posted at 5:56 PM, Nov 19, 2020

INDIANAPOLIS — A new drug treatment from Eli Lilly and Company to help hospitalized COVID-19 patients requiring oxygen has received emergency use authorization from the U.S. Food and Drug Administration.

Baricitinib, which is used in combination with remdesivir, can be given to both adult and pediatric patients two years old and older who are suspected to have or have a confirmed case of COVID-19 and need supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.

Baricitinib, an anti-inflammatory drug, is already approved and being used in more than 70 countries to help treat arthritis.

"Since the start of the COVID-19 pandemic, Lilly has been committed to finding potential treatments to help people around the world who've been impacted by this virus," David A. Ricks, Lilly chairman and CEO, said in a press release. "Today's FDA action for baricitinib marks the second Lilly therapy to be granted an EUA, in addition to the recent neutralizing antibody EUA for high-risk non-hospitalized patients, increasing the number of treatment options for COVID-19 patients at different stages of the disease. This is an important milestone for hospitalized patients on oxygen, as baricitinib may help speed their recovery."

Patients treated with the drug in combination with remdesivir had a "significant reduction in median time to recovery," according to the press release.

"What the study showed is a benefit in recovery from eight days to seven days," Ilya Yuffa, vice president of Eli Lilly Biomedicines, said. "Which when we think in the magnitude of number of patients that are hospitalized around the country, it's a significant benefit both for patients and for the hospital system."

Baricitinib has not been approved by the FDA to treat COVID-19 and studies are still underway in clinical trials, according to the press release.

Eli Lilly and Company is working with healthcare systems and governments to facilitate patient access to the drug.

"With respect to supply, Lilly remains confident in being able to meet the needs of patients under the EUA in the U.S., as well as for existing approved indications around the world," the press release read.

To learn more about the drug, click here.

Earlier this month, Eli Lilly and Company received an emergency use authorization for its experimental COVID-19 antibody treatment.

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Baricitinib is used in more severe cases of COVID-19 while the antibody treatment is used early in the disease, Yuffa said.