INDIANAPOLIS — Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the distribution of baricitinib. The authorization enables the use of baricitinib in combination with remdesivir in hospitalized patients needing oxygen.
“Since the start of the COVID-19 pandemic, Lilly has been committed to finding potential treatments to help people around the world who’ve been impacted by this virus,” said David A. Ricks, Lilly chairman and CEO.
This FDA action for baricitinib marks the second Lilly therapy to be granted an EUA. Recently, the FDA issued an emergency use authorization for a COVID-19 antibody treatment for high-risk non-hospitalized patients. Thursday’s announcement regarding baricitinib increases the number of treatment options for COVID-19 patients at different stages of the disease.
“This is an important milestone for hospitalized patients on oxygen, as baricitinib may help speed their recovery,” said Ricks.
Eli Lilly says this combination of baricitinib and remdesivir reduced recovery time by one day and made ventilation or death less likely.
“It showed an improvement to recovery and so you saw an improvement in recovery when combined with the use of remdesivir,” said Ilya Yuffa, President of Lilly Biomedicines.
Baricitinib is approved and commercially available as OLUMIANT in the U.S. and more than 70 countries as a treatment for adults with moderate to severe rheumatoid arthritis (RA).
The emergency use authorization from the FDA comes at a time when there are more than 80,000 people in the hospital with COVID-19 across the country. More than 3,000 of those hospitalizations are in Indiana. That is an increase of 75 percent since November 1.
“Even a day improvement in the impact not only is it a benefit for anyone who is able to recover more quickly but also the strain that it puts in the hospital system,” explained Yuffa.
On Friday, a World Health Organization panel advised against using remdesivir in hospitalized COVID-19 patients. Eli Lilly believes the evaluation of ACTT-2 data by the FDA supports the FDA’s decision to authorize baricitinib for emergency use in combination with remdesivir.
“WHO’s living guideline is based on a review of trials with different study designs, with the large open-label SOLIDARITY trial assessing treatment interventions on in-hospital mortality,” said a spokesperson for Eli Lilly. “The design of the ACTT trials sponsored by NIAID (i.e., randomized, placebo-controlled, double-blinded) is better suited to rigorously assess a time to recovery endpoint compared to a trial with an open-label design, and the SOLIDARITY results do not refute these findings of benefit to patients.”
The FDA grants emergency use authorization to provide availability of a medicine that may help diagnose, treat or prevent a life-threatening disease when no adequate and approved alternatives are available.
The authorization is temporary and does not replace the formal review and approval process. Evaluation of baricitinib’s efficacy and safety as a treatment for COVID-19 is ongoing in clinical trials.