ADD SUBJECT TO EMAIL ALERTS
Receive an email when new articles are published on
Please enter your email address to receive an email when new articles are published on . “data-action =” subscribe “> subscribe
We could not process your request. Please try again later. If this problem persists, please contact [email protected].
Back to Healio
According to a press release, the FDA has granted emergency approval to tocilizumab for the treatment of hospitalized patients receiving corticosteroids who require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation.
The emergency approval for tocilizumab (Actemra, Genentech) – now the fourth monoclonal antibody approved for COVID-19 – applies specifically to hospitalized adults and children aged 2 and over; it is not intended for outpatients or to treat COVID-19, the FDA noted.
The FDA has granted emergency approval for tocilizumab for the treatment of hospitalized patients receiving systemic corticosteroids and requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation. Source: Adobe Stock
“Today’s action shows the FDA’s commitment to making new therapies available at 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 successfully reduced the number of patients with COVID-19 who require hospitalization, providing additional therapies to those hospitalized is an important step in combating this pandemic.”
The FDA based its emergency approval on the results of four randomized, controlled trials – RECOVERY, EMPACTA, COVACTA, and REMDACTA – that examined the safety and effectiveness of tocilizumab in more than 5,500 hospitalized patients with COVID-19. In particular, the RECOVERY and EMPACTA studies provided “key scientific evidence of the potential benefits of Actemra for its approved use,” the FDA noted.
In the RECOVERY study, 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 by 28 days of follow-up.
According to the FDA, the “primary analysis results were statistically significant” with an estimated death rate of 30.7% for patients receiving tocilizumab and 34.9% for patients receiving standard care alone. In addition, the median time to hospital discharge was 19 days in the tocilizumab group compared to more than 28 days in the standard care group.
Supplementary data from the EMPACTA study, in which hospitalized patients with COVID-19 pneumonia (n = 389) were randomized to receive tocilizumab (n = 249) or standard treatment (n = 128), showed a lower risk of progression for mechanical ventilation or death by day 28 in hospitalized patients who received tocilizumab (12% vs. 19.3%).
“Even with the availability of vaccines and the decline in deaths from COVID-19 in different parts of the world, we continue to see new hospitalizations for more severe forms of the disease.” Levi Garraway, MD, PhD, Chief medical officer and head of global product development for Genentech, said in a company news release. “We are pleased that Actemra is now approved as an option that can help improve the outcomes of adults and children hospitalized with COVID-19 in the United States.”
Emergency clearance requires that healthcare providers and patients, parents, and caregivers be provided with fact sheets with information on possible side effects such as constipation, anxiety, diarrhea, insomnia, high blood pressure, and nausea.
ADD SUBJECT TO EMAIL ALERTS
Receive an email when new articles are published on
Please enter your email address to receive an email when new articles are published on . “data-action =” subscribe “> subscribe
We could not process your request. Please try again later. If this problem persists, please contact [email protected].
Back to Healio
