FDA Authorizes Actemra Drug for Treatment of COVID-19
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The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the drug Actemra (tocilizumab) for the treatment of hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Actemra is not authorized for use in outpatients with COVID-19.

In clinical trials of hospitalized patients with COVID-19, Actemra in addition to the routine care patients receive for treatment of COVID-19, which included corticosteroid therapy, was shown to reduce the risk of death through 28 days of follow-up and decrease the amount of time patients remained hospitalized. The risk of patients being placed on ventilators or death through 28 days of follow-up was also decreased.

The data supporting this EUA for Actemra are based on four clinical trials. These included one randomized, controlled, open-label, platform trial [Randomised Evaluation of COVID-19 Therapy (RECOVERY)] and three randomized, double-blind, placebo-controlled trials (EMPACTA, COVACTA and REMDACTA). While all four clinical trials contribute to the FDA’s understanding of Actemra for the treatment of COVID-19, the most important scientific evidence on the potential benefit of Actemra for its authorized use came from the RECOVERY and EMPACTA trials.

~ RECOVERY trial

In the RECOVERY trial, 4,116 hospitalized patients with severe COVID-19 pneumonia were randomized to receive either Actemra in addition to usual care (2,022 patients) or usual care alone (2,094 patients). The primary endpoint evaluated death through 28 days of follow-up, and the results of the primary analysis were statistically significant. The probabilities of death by day 28 were estimated to be 30.7% for patients receiving Actemra and 34.9% for patients receiving usual care alone. The median time to hospital discharge was 19 days for patients receiving Actemra and more than 28 days for patients receiving usual care alone.

~ EMPACTA trial

In the EMPACTA trial, 389 hospitalized patients with COVID-19 pneumonia were randomized to receive Actemra (249 patients) or placebo (128 patients). The primary endpoint evaluated the need for mechanical ventilation or death through 28 days of follow-up. For patients receiving Actemra, there was an observed reduction in progression to mechanical ventilation or death compared to patients who received placebo, with the primary analysis results being statistically significant. The proportion of patients who required mechanical ventilation or died by day 28 was estimated to be 12.0% for patients receiving Actemra and 19.3% for patients receiving placebo.

~ COVACTA trial

In the COVACTA trial, 452 hospitalized patients with severe COVID-19 pneumonia were randomized to receive Actemra (294 patients) or placebo (144 patients). The primary endpoint was clinical status through 28 days of follow-up assessed on a 7-category ordinal scale. While there was no statistically significant difference observed in clinical status on the 7-category ordinal scale at day 28 between treatment groups, the COVACTA trial contributed to the assessment of the safety for Actemra when used for the treatment of COVID-19.

~ REMDACTA trial

In the REMDACTA trial, 649 hospitalized patients with severe COVID-19 pneumonia were randomized to receive Actemra in combination with remdesivir (430 patients) or placebo in combination with remdesivir (210 patients). The primary endpoint was time to hospital discharge or “ready for discharge” through 28 days of follow-up. Additionally, while there were no statistically significant differences observed between treatment groups with respect to time to hospital discharge or “ready for discharge” through 28 days of follow-up, the REMDACTA trial contributed to the assessment of the safety for Actemra when used for the treatment of COVID-19.

Under the EUA, fact sheets that provide important information about using Actemra in treating COVID-19 as authorized must be made available to health care providers and to patients, parents, and caregivers. These fact sheets include dosing instructions, potential side effects and drug interactions. Common side effects of Actemra observed in the COVID-19 trials include constipation, anxiety, diarrhea, insomnia, hypertension and nausea.

Source:
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-drug-treatment-covid-19
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