Eli Lilly and Incyte’s Olumiant program for lupus will be discontinued after mixed results from late-stage clinical trials failed to demonstrate the drug’s effectiveness. Olumiant is also facing rough waters in its approval for moderate-to-severe atopic dermatitis, also known as eczema, with a potential stoppage from the U.S. FDA looming.
Olumiant in lupus
Olumant (baricitinib) failed to meet several key endpoints in two phase 3 clinical trials. Although the 4-mg oral dose of baricitinib showed a significant reduction in disease activity in one study, it did not do so in the second. Key secondary endpoints were not met in either study, said Lilly.
Safety findings did not have an impact on the company’s decision to stop moving forward with the program. The Indianapolis-based company said it is working with investigators to properly conclude the phase 3 clinical trial.
Olumiant in eczema
Meanwhile, Olumiant’s sNDA for use in eczema treatment could also be in trouble. In the EU and Japan, Olumiant was the first JAK inhibitor approved to treat moderate to severe patients with atopic dermatitis. But in the U.S., the drugmaker's petition to the FDA to approve the drug for use by adults with moderate-to-severe eczema has been rocky, with review timelines being extended repeatedly.
According to Lilly, the CRL may come due to disagreements between the agency and the drugmaker over the indicated population of treatment use. Despite this, drug safety does not appear to be an issue and data has stayed consistent.
Despite recent setbacks, Olumiant has found some success in another arena — COVID-19 treatments. The drug, initially approved by the FDA to treat rheumatoid arthritis in May 2018, has been granted an EUA by the FDA for treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen.
