In what the FDA calls “an incremental step” in treating hospitalized COVID-19 patients, the agency has issued an emergency use authorization (EUA) for Eli Lilly and Co.’s baricitinib in combination with remdesivir.

The decision was made based on initial data from the Adaptive COVID-19 Treatment Trial by Lilly and Incyte Corp., of Wilmington, Del., which found about a one-day reduction in median recovery time for the overall patient population treated with baricitinib in combination with remdesivir vs. those treated with remdesivir. The finding was considered statistically significant.

“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, the FDA’s acting director of its Center for Drug Evaluation and Research.

The EUA targets suspected or laboratory-confirmed COVID-19 in hospitalized adults and pediatric patients ages 2 or older who require supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation.

The study defined recovery as the patient being well enough for hospital discharge. Participants should no longer require supplemental oxygen or ongoing medical care in the hospital or no longer be hospitalized at day 29.

The study also met a key secondary endpoint comparing patient outcomes at day 15 using a scale that ranged from fully recovered to death.

Remdesivir is FDA approved as an I.V. antiviral for treating hospitalized COVID-19 adults and pediatric patients ages 12 and older and weighing at least 40 kilograms, which is about 88 lbs. It also has an EUA for treating suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg, about 7.7 lbs., to less than 40 kg or hospitalized pediatric patients under 12 weighing at least 3.5 kg.

The Adaptive study was conducted by the U.S. NIH’s National Institute of Allergy and Infectious Diseases.

Baricitinib is not just for COVID-19 patients. It is FDA approved at Olumiant for treating moderately to severely active rheumatoid arthritis. In addition, Lilly and Incyte have the JAK1/JAK2 inhibitor in a phase III trial for treating moderate to severe atopic dermatitis. Plus, Lilly is putting baricitinib through the paces in a phase II study of treating alopecia areata.

No Comments