Arthritis drug Actemra receives FDA EUA for treating COVID-19 patients

The U.S. Food and Drug Administration has issued an emergency use authorization (EUA), of the drug Actemra (tocilizumab) for treatment of hospitalized COVID-19 patients.

Actemra, which is mainly used for arthritis treatment, can only be administered to pediatric patients (2 years and above), and hospitalized adults who are on systemic corticosteroids, and require oxygen therapy, extracorporeal membrane oxygenation (ECMO), or invasive/ non-invasive mechanical ventilation.

Clinical trials have revealed that administration of Actemra to hospitalized COVID-19 patients, along with continued routine care which consists of corticosteroid therapy, decrease the risk of death as well as the average time of hospitalization.

Reduced risk among patients who were placed on ventilators, and subsequently dying was also observed in the trial. However, the drug has not been authorized for use in outpatients with COVID-19, according to a statement given by the FDA.

MD, Director of the FDA's Center for Drug Evaluation and Research, Patrizia Cavazzoni, was quoted saying that although vaccines have been effective in reducing the number of COVID-19 patients requiring hospitalization, ensuring adequate care and therapy for those who do become hospitalized is a vital step towards overcoming the pandemic.

It is worth noting that, Actemra (tocilizumab), is a monoclonal antibody that lowers inflammation and is administered by intravenous infusion that is FDA-approved for the treatment of rheumatoid arthritis and several other inflammatory diseases.

Market experts have stated that the COVID-19 infection causes the immune system to become hyperactive, which may result in a rapid decline of patients’ health.

The data supporting FDA’s EUA for Actemra, which has been based on four clinical trials, gives reasonable evidence to believe that the drug may be effective in treating COVID-19 for the sanctioned population.

Common side effects of Actemra as ascertained in the COVID-19 trials include anxiety, constipation, diarrhea, hypertension, insomnia, and nausea.

The FDA has also revealed that the EUA has been issued to American biotechnology corporation, Genentech Inc.

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