The FDA authorisation allows emergency use of Actemra for the treatment of Covid-19 in hospitalised adult and paediatric patients
Genentech’s Actemra granted FDA EUA. (Credit: Thor Deichmann from Pixabay.)
Roche’s subsidiary Genentech has received the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for Actemra (tocilizumab) to treat severe Covid-19 in adults and children aged two years and above.
The drug is indicated for hospitalised Covid-19 patients, who are on systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Actemra is a humanised interleukin-6 (IL-6) receptor antagonist, approved to treat active rheumatoid arthritis (RA) in patients previously treated with one or more disease-modifying antirheumatic drugs (DMARDs).
It was also approved to treat giant cell arteritis (GCA), active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA) and systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Genentech CEO Alexander Hardy said: “Industries, governments and academic institutions have come together to develop solutions to address the enormous challenges of the pandemic.
“We are proud of the partnerships that we’ve created and the progress we’ve made in conducting scientifically rigorous trials of Actemra in Covid-19.
“We are committed to collaborating closely with our distribution partners to enable access to Actemra in hospitals across the country to help adults and children with Covid-19, as well as people who depend on the medicine for its FDA-approved indications.”
The EUA is based on results from four randomised, controlled clinical studies that evaluated Actemra for the treatment of Covid-19 in more than 5,500 hospitalised patients.
The four studies include the RECOVERY Actemra study, led by the UK researchers, and Genentech-sponsored placebo-controlled trials EMPACTA, COVACTA and REMDACTA.
Results from the clinical studies suggest that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.
In the studies, the most common adverse reactions include constipation, anxiety, diarrhoea, insomnia, hypertension and nausea, and no new safety signals were identified.
Roche chief medical officer and global product development head 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.”