EUA Expanded for Lilly COVID Combo Therapy
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The U.S. Food and Drug Administration has expanded the Emergency Use Authorization for a combination therapy developed by Indianapolis-based Eli Lilly and Co. (NYSE: LLY) to treat patients with COVID-19. Lilly says bamlanivimab and etesevimab can now be used to treat certain high-risk pediatric patients from birth to 12 years old.
The company says the expansion is based on a Phase 2/3 clinical trial of the combination therapy being administered for the treatment of mild-to-moderate COVID-19 among pediatric and infant patients, as well as those who are at high risk for severe disease progression.
“Our mission since the start of the pandemic has been to offer crucial support by developing therapeutic options that could prevent hospitalization and death for as many people as possible,” said Dr. Daniel Skovronsky, chief scientific and medical officer at Lilly and president of Lilly Research Laboratories. “With the FDA’s decision to allow use of bamlanivimab with etesevimab in children and infants, Lilly can now offer treatment and prevention options to high-risk individuals of any age.”
The combination therapy initially received an EUA in February for use in patients 12 years and older.
Lilly says, to date, more than 700,000 patients have been treated with either the combination therapy or bamlanivimab alone.