FDA grants emergency use authorization for Lilly’s baricitinib as combination COVID-19 treatment

Eli Lilly, and Incyte have received Emergency Use Authorization from the Food and Drug Administration for the distribution and emergency use of baricitinib to be used in combination with remdesivir in hospitalized adult and pediatric patients two years of age or older with suspected or laboratory confirmed COVID-19 who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation.           

"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 Ricks, Lilly chairman and CEO. "Today's FDA action for baricitinib marks the second Lilly therapy to be granted an EUA, in addition to the recent neutralizing antibody EUA for high-risk non-hospitalized patients, increasing 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."

"As a company, we have worked quickly and collaboratively to determine the potential utility of our medicines as treatments for COVID-19 and its related complications," said Hervé Hoppenot, Incyte CEO. "We are pleased that the FDA has authorized the use of baricitinib in combination with remdesivir for COVID-19, and look forward to the opportunity to make more therapies available to patients around the world affected by the global pandemic."    

"The results of ACTT-2 provide physicians and the medical community much-needed insights and randomized placebo-controlled evidence supporting the use of baricitinib in combination with remdesivir for the treatment of hospitalized patients with COVID-19; also importantly, the progression to ventilation or death was significantly reduced with the baricitinib-remdesivir combination," said Andre Kalil, professor at the University of Nebraska Medical Center and a principal investigator of the ACTT studies. "Few treatment options have received an EUA to treat COVID-19 so the authorization of baricitinib is an important step that will give healthcare providers another clinical tool to help patients with advanced disease."

This is the first combination regimen authorized by FDA. Evaluation of baricitinib's efficacy and safety as a treatment for COVID-19 is ongoing in clinical trials.