Eli Lilly And Co’s LLY rheumatoid arthritis drug baricitinib has been issued an emergency use authorization, in combination with Gilead Sciences, Inc’s GILD remdesivir, for the treatment of COVID-19 in adults and children who are hospitalized and require supplemental oxygen and other supportive ventilation measures.
What Happened: The Food and Drug Administration said in a statement that baricitinib — sold under the brand name Olumiant — led to recovery within 29 days of initiating treatment compared to patients who only received remdesivir, in a clinical trial of hospitalized patients with COVID-19.
“The FDA’s emergency authorization of this combination therapy represents an incremental step forward in the treatment of COVID-19 in hospitalized patients, and FDA’s first authorization of a drug that acts on the inflammation pathway,” said Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research.
Patients treated with baricitinib had a “significant reduction in median time to recovery” from eight to seven days compared with remdesivir monotherapy, Eli Lilly said in a statement.
The drugmaker also pointed to other clinical improvements like the number of patients — who had progressed to ventilation (both invasive and non-invasive) or died by Day 29 — was 23% for those treated with baricitinib and remdesivir and 28% in case of remdesivir alone.
Eli Lilly CEO David Ricks described the FDA’s grant of emergency authorization as an “important milestone” for hospitalized patients on oxygen.
Why It Matters: Baricitinib has become the second Eli Lilly therapy to be granted a EUA by the federal agency.
This month, Eli Lilly’s antibody treatment for COVID-19 — bamlanivimab — the FDA emergency approval for treatment of COVID-19 in non-hospitalized patients.
The antibody treatment was found ineffective for the treatment of hospitalized patients in a study conducted by the National Institute of Allergy and Infectious Diseases.
Gilead’s remdesivir was granted FDA emergency use authorization to treat COVID-19 in May and received full approval in October.
Price Action: Eli Lilly shares closed almost 2.3% higher at $143.41 on Thursday and gained 0.4% in the after-hours session. On the same day, Gilead shares closed nearly 0.4% lower at $60.63 and fell 1.62% in the after-hours session.
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