Lilly’s Olumiant Runs Into Headwinds as COVID-19 Treatment

Less than a month after receiving an Emergency Use Authorization (EUA) for rheumatoid arthritis drug Olumiant (baricitinib) to treat COVID-19, Eli Lilly is facing questions about the drug’s efficacy in treating the pandemic disease.

The EUA issued Nov. 19 is for Olumiant in combination with Gilead Sciences’ antiviral Veklury (remdesivir) for the treatment of hospitalized COVID-19 patients needing supplemental oxygen.

The approval was supported by results from a phase 3 study, dubbed ACTT-2 and supported by the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases, that showed the combination treatment reduced COVID-19 patient recovery time (until discharged from the hospital or no longer requiring ongoing medical care) by 12.5 percent, or from eight to seven days, vs. remdesivir alone. But the one-day reduction in recovery time comes with serious side effects in some patients, including blood clots.

Reportedly, the drug’s price tag is steep at $1,500. However, the company disputed that estimate, saying Monday that “costs for patients with commercial health insurance are “around $150 per day for a 4-mg dose — with limited impact on patient out-of-pocket costs.” For a seven-day course of treatment, that works out to $1,050.

The trial results for the Eli Lilly drug were favorable and included adverse events and serious adverse events in 41 percent and 15 percent of patients treated with baricitinib in combination with remdesivir, respectively, compared to 48 percent and 20 percent in patients treated with remdesivir alone, the company said in its Nov. 19 statement. The trial results have yet to be published in a peer-reviewed journal.

Also, “infections and venous thromboembolism (VTE) occurred in 6 percent and 4 percent of patients treated with baricitinib in combination with remdesivir, respectively, vs. 10 percent and 3 percent of patients treated with remdesivir,” the company said.

Eli Lilly says in its email to FDAnews that in the ACTT-2 study of the drug, the patients who needed supplemental oxygen or high-flow oxygen/noninvasive ventilation at the beginning benefited the most from baricitinib. Additionally, the proportion of patients who needed ventilation or died by day 29 was lower at 23 percent in patients treated with baricitinib plus remdesivir, compared to remdesivir alone at 28 percent, the company says.

In response to questions about the Eli Lilly drug, the NIH announced an additional study at the end of November in hospitalized COVID-19 patients. This study will have two arms: baricitinib with remdesivir or remdesivir with the steroid dexamethasone. Many doctors have favored dexamethasone because it is a widely used drug with well-known side effects and is much cheaper than baricitinib. Lilly is separately studying baricitinib with dexamethasone in hospitalized COVID-19 patients. — Martin Berman-Gorvine