Genentech, affiliated to Swiss drug major Roche Holding AG (RHHBY), announced Monday that the U.S. Food and Drug Administration has accepted its supplemental Biologics License Application or sBLA and has granted Priority Review for Actemra (tocilizumab) intravenous or IV to treat COVID-19 in hospitalized adults.
A decision on FDA approval is expected in the second half of this year.
Actemra is for the treatment of COVID-19 in hospitalized adults who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation or ECMO.
The sBLA submission is based on results from four randomized, controlled studies that evaluated Actemra for the treatment of COVID-19 in more than 5,500 hospitalized patients.
The results of these four studies, such as EMPACTA, COVACTA, REMDACTA and RECOVERY, suggest that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.
EMPACTA was the first global, Phase III study to focus on patients from underrepresented racial and ethnic groups. There have been no new safety signals identified for Actemra in these studies.
The most common adverse reactions were constipation, anxiety, diarrhea, insomnia, hypertension and nausea.
In June 2021, Actemra received Emergency Use Authorization from the FDA, and is currently approved for use in 16 countries around the world for defined patients hospitalized with severe or critical COVID-19. Actemra subcutaneous or SC is not authorized for the treatment of COVID-19 patients under the EUA.
In February 2022, the World Health Organization prequalified Actemra for patients with severe or critical COVID-19, supporting access to care in low- and middle-income countries.
The company noted that more than one million people with severe or critical COVID-19 have already been treated with Actemra worldwide.
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