By releasing new data on Olumiant in COVID-19 earlier this week, Eli Lilly joined a short list of companies with real results against the deadly virus. Filing for an emergency authorization from the FDA may not be far behind—and, if granted, Lilly says it's "extremely well-positioned" to supply the drug.
In trial results unveiled Monday, patients treated with Olumiant—in combination with Gilead Sciences' remdesivir—recovered faster than those on remdesivir alone. The difference was about one day at the median, significant enough to prompt Lilly to take the data to the FDA.
An oral tablet approved to treat rheumatoid arthritis, Olumiant is a small molecule that's easy to produce, and it's already used widely all over the world, Lilly Bio-Medicines President Patrik Jonsson said in a Tuesday interview. Lilly could use its existing commercial channels and distribution systems for the medicine in COVID-19.
If blessed by the FDA, Olumiant would become the third therapy currently cleared to treat COVID-19 in the U.S. after remdesivir, now sold under the brand name Veklury, and convalescent plasma. Aside from the FDA, Lilly is planning to discuss the data with regulatory bodies in Europe and elsewhere. Jonsson said there has "already been some interest expressed" among regulators outside the U.S.
Monday's results, from a trial called ACTT-2, grew from research that began early in the pandemic. As the outbreak gathered steam, Lilly started an internal review of its existing medicines that might be able to “make a difference” in COVID-19, Jonsson said. Then, a company called BenevolentAI published an article in The Lancet making a case for the rheumatoid arthritis drug.
Lilly “accelerated our effort internally” in response to the article, Jonsson said. Meanwhile, the company also heard from doctors around the world who were using the arthritis drug in COVID-19 patients.
The company initially posited that Olumiant might benefit COVID-19 patients in two ways, said Anabela Cardoso, Lilly’s global brand development lead for immunology. The company figured it could fight inflammation and quell the cytokine response that can be so dangerous to some COVID-19 patients.
A “more exploratory hypothesis” was that the drug might attack the virus directly by inhibiting some proteins. The company has yet to prove that potential mechanism, she said.
The National Institute of Allergy and Infectious Diseases conducted the ACTT-2 trial in partnership with Lilly, and now the agency is reviewing the data to assess whether the drug helps patients survive COVID-19 illness. It's also examining the drug's effects in various subgroups, Jonsson said.
Jonsson expects the results to be published in a peer-reviewed journal in a few weeks. The trial tested the medicine plus remdesivir against remdesivir alone in more than 1,000 patients.
The data are important, because the study examined Olumiant and remdesivir's benefit in severe patients with few options, Jonsson said. Plus, Olumiant “added benefit on a relatively high standard already," noting remdesivir's proven efficacy in shortening recovery time.
The drug hit a secondary endpoint as well by improving clinical outcomes at Day 15. That’s a measure of how much clinical support patients require, Jonsson said. Those who received Olumiant and remdesivir “needed significantly less clinical support” than those on remdesivir alone, Jonsson said. That could reduce burdens on healthcare systems as they grapple with treating surges of patients.
Aside from the National Institute of Allergy and Infectious Diseases-partnered work, Lilly is testing Olumiant against standard care in its own randomized trial, with those results expected toward the end of the year, Jonsson said.
And outside of Olumiant, the company is testing whether an early-stage oncology drug could reduce the risk of acute respiratory distress syndrome in COVID-19 patients. Plus, the company on Wednesday rolled out early data for a novel antibody partnered with AbCellera. The release highlighted a reduced hospitalization rate for mild to moderate patients treated with the antibody, but analysts raised questions about the significance of the data.