The US Food and Drug Administration (FDA) has extended the Emergency Use Authorization (EUA) for Eli Lilly and Company and Incyte’s baricitinib to treat Covid-19 patients with or without remdesivir.
The latest move follows EUA approved by FDA for baricitinib restricted to use only in combination with remdesivir in November last year.
Now, the EUA enables the use of baricitinib in hospitalised adults and paediatric Covid-19 patients two years of age or above who require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
Discovered by Incyte and licensed to Lilly, Baricitinib is an oral JAK inhibitor that is approved and commercially available as Olumiant in the US and more than 75 countries to treat adults with moderate to severe rheumatoid arthritis (RA).
It is now authorised for emergency use as monotherapy.
Lilly Bio-Medicines senior vice president and president Ilya Yuffa said: “Baricitinib in combination with remdesivir has already provided many people with a treatment option that could help prevent progression to ventilation or death and increase recovery speed for certain hospitalized patients with COVID-19 under its currently authorized use.
“Today’s FDA action provides physicians additional treatment regimen options for baricitinib to continue to meet the urgent medical needs posed by this pandemic.
“Based on the increasing body of evidence, we are confident in the potential of baricitinib as an important treatment for the hospitalized COVID-19 patient population requiring supplemental oxygen.”
The latest FDA approval was based on data obtained from the Phase III COV-BARRIER study, a randomized, double-blind, placebo-controlled study on hospitalised patients.
In this study, the scientists have compared baricitinib 4 mg once daily plus standard care against placebo plus standard care and found that patients on baricitinib were less likely to progress to ventilation or death.
In a separate development, Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company, has collaborated with Kumquat Biosciences to jointly develop and commercialise novel small molecules that stimulate tumor-specific immune responses.