EMA Evaluates Olumiant for Hospitalized COVID-19 Patients

The European Medicines Agency (EMA) is reviewing Eli Lilly’s arthritis drug Olumiant (baricitinib) as a possible treatment for hospitalized COVID-19 patients age 10 years and older who require supplemental oxygen.

The immunosuppressant works by inhibiting Janus kinase enzymes that cause inflammation and tissue damage seen in severe COVID-19 infections.

The EMA’s human medicines committee will evaluate data from two large studies and hopes to make a recommendation on the drug by July.

In one phase 3 study, the drug significantly reduced the risk of death but failed to significantly reduce progression to noninvasive ventilation for COVID-19 patients (DID, April 9).

Olumiant is also currently being evaluated in the UK’s RECOVERY trial of multiple candidate treatments, including Roche’s arthritis drug Actemra (tocilizumab), Regeneron’s antibody cocktail (casirivimab and imdevimab), dimethyl fumarate and aspirin.

In the U.S., Olumiant received FDA Emergency Use Authorization in November 2020 in combination with Gilead Sciences’ Veklury (remdesivir) for treating COVID-19 patients age two years and older who need supplemental oxygen (DID, Nov. 23, 2020). — Jason Scott