The indication is for intravenous use of the drug in both adult and paediatric patients aged two years and above who are on systemic corticosteroids and need supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
Actemra is a humanised interleukin-6 (IL-6) receptor antagonist approved for treating rheumatoid arthritis, giant cell arteritis and polyarticular juvenile idiopathic arthritis among other conditions.
The FDA authorisation for Covid-19 treatment is based on data from four randomised, controlled clinical trials of the drug in a total of more than 5,500 hospitalised patients.
Data showed that Actemra could improve outcomes in Covid-19 patients who are taking corticosteroids and require supplemental oxygen or breathing support.
One of the four trials, referred to as the RECOVERY Actemra study, was led by investigators in the UK and involved more than 4,000 hospitalised patients with Covid-19.
The other three trials, EMPACTA, COVACTA and REMDACTA, were funded by Roche.
EMPACTA and COVACTA were multi-centre Phase III trials conducted in hospitalised patients with pneumonia related to Covid-19.
Roche collaborated with Gilead Sciences to carry out the double-blind, multi-centre Phase III REMDACTA trial of Actemra plus Veklury (remdesivir) in hospitalised Covid-19 patients with severe pneumonia.
In all the trials, the drug lowered the risk of death through 28 days of follow-up and reduced the duration of hospital stay, FDA noted. The risk of ventilation or death through the follow-up was also reduced.
No new Actemra-related safety signals were reported in these trials. The most common adverse reactions were constipation, anxiety, diarrhoea, insomnia, hypertension and nausea.
Roche Global Product Development head and chief medical officer Levi Garraway said: “Even with the availability of vaccines and declines in deaths from Covid-19 in various parts of the world, we continue to see new hospitalisations from severe forms of the disease.
“We are pleased that Actemra is now authorised as an option that may help improve outcomes for adults and children hospitalised with Covid-19 in the United States.”