Washington: The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) — used for arthritis — for the treatment of hospitalised patients with COVID-19.
Under the EUA, the drug can be administered only to hospitalised adults and pediatric patients (2 years of age and older), receiving systemic corticosteroids and requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
However, Actemra is not authorised for use in outpatients with COVID-19, the FDA said in a statement.
Clinical trials showed that administering Actemra to hospitalised COVID-19 patients, in addition to routine care which included corticosteroid therapy, reduced the risk of death as well as decreased the amount of time patients remained hospitalised.
The risk of patients being placed on ventilators or death was also decreased.
“Although vaccines have been successful in decreasing the number of patients with COVID-19 who require hospitalisation, providing additional therapies for those who do become hospitalised is an important step in combating this pandemic,” said Patrizia Cavazzoni, MD, Director of the FDA’s Center for Drug Evaluation and Research.
Actemra is a monoclonal antibody that reduces inflammation and is given by intravenous infusion that is FDA-approved for multiple inflammatory diseases, including rheumatoid arthritis.
In the case of COVID-19 infection, the immune system can become hyperactive, which may result in worsening of disease. But, Actemra does not directly target SARS-COV-2.
Based on the FDA’s review of the totality of the scientific evidence available, the agency has determined that it is reasonable to believe that Actemra may be effective in treating COVID-19 for the authorised population.
The data supporting this EUA for Actemra are based on four clinical trials. All four clinical trials contribute to the FDA’s understanding of Actemra for the treatment of COVID-19.
Common side effects of Actemra observed in the COVID-19 trials include constipation, anxiety, diarrhoea, insomnia, hypertension and nausea. The EUA was issued to American biotechnology Genentech, a subsidiary of Swiss multinational healthcare Roche, FDA said.