The National Institute of Allergy and Infectious Diseases (NIAID) in the US has announced results from a Phase III study which show how baricitinib plus remdesivir reduced recovery time for people hospitalised with Covid-19.
Discovered by Incyte and licensed to Eli Lilly and Company, baricitinib is an anti-inflammatory drug while remdesivir is an antiviral treatment developed by Gilead Sciences.
The peer-reviewed results from the second iteration of the National Institutes of Health (NIH) Adaptive COVID-19 Treatment Trial (ACTT-2) were published in The New England Journal of Medicine .
The data supported the US Food and Drug Administration’s (FDA) decision to grant emergency use authorisation (EUA) for the combination in hospitalised patients with Covid-19 needing supplemental oxygen.
In May, the trial sponsored by the NIAID was launched to assess remdesivir plus baricitinib for treating Covid-19.
The Phase III study enrolled 1,033 patients from 67 trial sites in eight countries.
In the trial, participants were randomly given either oral baricitinib tablets in combination with intravenous (IV) remdesivir or oral placebo tablets plus IV remdesivir.
Data from the study showed that the combination reduced the median recovery time in hospitalised Covid-19 patients from eight days to seven days.
On receiving the combination therapy, those needing high-flow oxygen or non-invasive ventilation during hospitalisation had the largest benefit. Data showed that their median time to recover was reduced from 18 days to ten days.
At day 15, conditions of subjects significantly progressed on receiving baricitinib plus remdesivir.
Eli Lilly immunology global brand development lead and New England Journal of Medicine paper author Anabela Cardoso said: “Presently, there are limited published placebo-controlled data assessing treatment options to manage the symptoms and progression of Covid-19.
“We need high-quality research such as the ACTT-2 study to evaluate therapies to fight this pandemic and are pleased that this medicine is now available for patients under EUA.”
