Baricitinib plus remdesivir is indicated for Covid-19 patients who require supplemental oxygen, invasive mechanical ventilation, or ECMO
The US Food and Drug Administration (FDA) has granted an Emergency Use Authorisation (EUA) for the use of baricitinib, in combination with remdesivir, to treat hospitalised Covid-19 patients.
The drug regimen is indicated for patients aged two years or above, with suspected or laboratory-confirmed Covid-19 infection, who require supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Baricitinib is an oral JAK inhibitor, discovered by Incyte and licensed to Lilly. The drug has been approved and is available in the US, under the brand name Olumiant.
Also, the drug is approved in more than 70 countries for the treatment of moderate to severe rheumatoid arthritis (RA) and was recently approved in the EU for moderate to severe atopic dermatitis who are eligible for systemic therapy.
Lilly chairman and CEO David A Ricks said: “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.
“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-hospitalised patients, increasing the number of treatment options for Covid-19 patients at different stages of the disease.
“This is an important milestone for hospitalised patients on oxygen, as baricitinib may help speed their recovery.”
The US regulatory agency has granted the EUA based on data from the Adaptive Covid-19 Treatment Trial (ACTT-2), a randomised double-blind, placebo-controlled study.
Conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), the study evaluated the efficacy and safety of baricitinib plus remdesivir compared to placebo plus remdesivir in hospitalised Covid-19 patients.
All patients received standard supportive care, and a recommended dose for of baricitinib 4mg once daily for 14 days or until hospital discharge, said the company.
In the study, patients treated with baricitinib plus remdesivir showed better clinical status after 15 days compared to patients treated with remdesivir.
ACTT studies principal investigator Andre Kalil said: “The results of ACTT-2 provide physicians and the medical community much-needed insights and randomised placebo-controlled evidence supporting the use of baricitinib in combination with remdesivir for the treatment of hospitalised patients with Covid-19; also importantly, the progression to ventilation or death was significantly reduced with the baricitinib-remdesivir combination.
“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.”