FDA issues EUA for tocilizumab to treat patients hospitalized with COVID-19
The FDA has issued an emergency use authorization for tocilizumab to treat hospitalized patients receiving corticosteroids who require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation, according to a press release.
The emergency use authorization for tocilizumab (Actemra, Genentech) — now the fourth monoclonal antibody authorized for COVID-19 — is specifically for hospitalized adults and children aged 2 years and older; it is not intended for outpatients or as a treatment for COVID-19, the FDA noted.
“Today’s action demonstrates the FDA’s commitment to making new therapies available through every stage of the global COVID-19 pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “Although vaccines have been successful in decreasing the number of patients with COVID-19 who require hospitalization, providing additional therapies for those who do become hospitalized is an important step in combating this pandemic.”
The FDA based its emergency use authorization on results from four randomized, controlled trials — RECOVERY, EMPACTA, COVACTA and REMDACTA — that evaluated the safety and efficacy of tocilizumab in more than 5,500 hospitalized patients with COVID-19. In particular, the RECOVERY and EMPACTA trials provided the “most important scientific evidence on the potential benefit of Actemra for its authorized use,” the FDA noted.
In the RECOVERY trial, hospitalized patients with severe COVID-19 pneumonia (n=4,116) were randomized to receive either tocilizumab plus standard care (n=2,022) or standard care alone (n=2,094). The primary endpoint was death through 28 days of follow-up.
According to the FDA, the “results of the primary analysis were statistically significant” with the probability of death by day 28 estimated to be 30.7% for patients receiving tocilizumab and 34.9% for patients receiving standard care alone. Additionally, the median time to hospital discharge was 19 days in the tocilizumab group compared with more than 28 days in the standard care group.
Supplemental data from the EMPACTA trial, in which hospitalized patients with COVID-19 pneumonia (n=389) were randomized to receive tocilizumab (n=249) or standard care (n=128), demonstrated a lower risk for progression to mechanical ventilation or death by day 28 in hospitalized patients who received tocilizumab (12% vs. 19.3%).
“Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalizations from severe forms of the disease,” Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, said in a company press release. “We are pleased that Actemra is now authorized as an option that may help improve outcomes for adults and children hospitalized with COVID-19 in the United States.”
The emergency use authorization requires that fact sheets be made available to health care providers and patients, parents and caregivers featuring information on the potential side effects, which include constipation, anxiety, diarrhea, insomnia, hypertension and nausea.