FDA Authorizes Eli Lilly’s Arthritis Drug Olumiant in Combination With Remdesivir

The FDA has granted an Emergency Use Authorization (EUA) for Eli Lilly’s rheumatoid arthritis drug Olumiant (baricitinib) in combination with Gilead Sciences’ antiviral Veklury (remdesivir) for treatment of COVID-19 patients needing supplemental oxygen.

The approval was supported by results from a phase 3 study that showed the combination treatment reduced COVID-19 patient recovery time by 12.5 percent, or from eight to seven days, vs. remdesivir alone (DID, Oct. 13).

In related research in Europe, a baricitinib treatment alone was shown to reduce mortality by 71 percent in elderly patients (DID, Nov. 17).

Olumiant is currently approved in the U.S. for treating adult patients with moderate-to-severe active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.

Eli Lilly has said it expects to be able to scale up manufacturing operations to meet global demand for Olumiant for both arthritis and COVID-19 treatments. The company last week announced a long-term agreement with South Korea’s Samsung Biologics to increase production of COVID-19 neutralizing antibodies treatments (DID, Nov. 19).

Remdesivir has received a warmer welcome from U.S. regulators than from the agency’s international counterparts and the World Health Organization is not recommending it as a treatment for COVID-19 patients (see related story). ― Jason Scott