The U.S. Food and Drug Administration has issued another Emergency Use Authorization for a COVID-19 treatment developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY). The latest EUA allows for the distribution and emergency use of baricitinib, which was originally developed for the treatment of rheumatoid arthritis.
The authorization specifically allows healthcare providers to use baricitinib, in combination with remdesivir, in “hospitalized adult and pediatric patients two years of age or older with suspected or laboratory confirmed cases of COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.”
The EUA was granted based on data from an Adaptive COVID-19 Treatment Trial, or ACTT-2. Lilly says patients treated with baricitinib in combination with remdesivir had a significant reduction in median time to recovery from 8 to 7 days, and also were more likely to have a better clinical status at Day 15 compared to patients treated solely with remdesivir.
“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,” Lilly Chief Executive Officer Dave Ricks said in a news release. “This is an important milestone for hospitalized patients on oxygen, as baricitinib may help speed their recovery.”
Lilly says baricitinib has not received FDA approval. However, evaluation of the drug’s efficacy and safety as a treatment for COVID-19 continues in ongoing clinical trials.
Last week, Lilly received an EUA for the use of its COVID-19 antibody therapy, bamlanivimab. The company says it plans to manufacture up to one million doses of bamlanivimab by the end of the year, with 300,000 doses going to the U.S. government for distribution.