This week, Eli Lilly and Company announced additional findings indicating that its rheumatoid arthritis drug, baricitinib, may improve the health of severe Covid-19 patients when used in combination with Gilead Science’s antiviral drug remdesivir.
Outcomes of the study, which the company had reported preliminary data from in September, suggest that the two drugs in combination reduce hospitalization stays by one day compared to the use of remdesivir alone. The data also indicates that the drug combination increases chances of severe Covid-19 patients surviving by about 35%. That increase was more pronounced in those patients who required supplemental oxygen.
“We’re obviously extraordinarily pleased that it has an impact on the mortality rate,” says Ilya Yuffa, president of Lilly Biosciences.
The findings come from a large study called the Adaptive Covid-19 Treatment Trial (ACTT-2), which is sponsored by the National Institutes of Health. The full data and study writeup will be submitted to a peer-reviewed journal for publication.
“The data continues to look encouraging,” Dr. Amesh Adalja, an infectious disease expert at Johns Hopkins University Center For Health Security who is not affiliated with the study said in an email. “However it’s important to remember that we need to see how this drug does in those not only on remdesevir but on dexamethasone as well to understand it’s additive benefit (especially as the benefit is pronounced in those requiring oxygen who also would be candidates for dexamethasone).”
The comparison to dexamethasone is of particular interest, as it’s been used for patients with severe cases of Covid-19 since a large-scale trial in the U.K. suggested it might be beneficial. Dexamethasone is also one of the drugs that President Trump received to treat his Covid-19 infection.
Baricitinib is currently approved for use as an anti-inflammatory treatment for people who have rheumatoid arthritis. A study published in February by drug discovery company Benevolent AI suggested it was one of several drugs that may be able to help patients with severe cases of Covid-19.
ACTT-2, which began on May 8, is one of several studies that the NIH is doing to determine the impact of using other drugs in combination with remdesivir. Over 1,000 patients were enrolled in the study, which compared outcomes of patients receiving a combination of baricitinib plus remdesivir to patients who received remdesivir alone.
The next step, says Yuffa, is that Lilly will pursue an Emergency Use Authorization with the FDA for its drug to be used with Covid-19 patients. Additionally, Yuffa says that Lilly will continue its ongoing clinical trial comparing baricitinib to other Covid-19 treatments.
This is the second drug that Lilly will be taking to the FDA for Covid-19 patients. Earlier this week, the company announced that it would also be seeking emergency authorization for its monoclonal antibody treatment. That treatment is aimed at reducing hospitalization rates for Covid-19, especially for patients with mild or moderate symptoms.
“Lilly is committed to working with the scientific community and with government agencies in working quickly,” Yuffa says. “and putting all of our efforts behind this so we can fight the pandemic.”
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