U.S. FDA Grants Priority Review to Genentech’s Actemra for the Treatment of COVID-19 in Hospitalized AdultsApril 4, 2022
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and has granted Priority Review for Actemra (tocilizumab) intravenous (IV) 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 (ECMO). A decision on U.S. FDA approval is expected in the second half of this year.
“The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalized with COVID-19,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “More than one million people with severe or critical COVID-19 have already been treated with Actemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic.”
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. Altogether, the results of these four studies (EMPACTA, COVACTA, REMDACTA and RECOVERY) suggest that Actemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support. One of these studies, 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 seen (incidence ≥ 3%) are constipation, anxiety, diarrhea, insomnia, hypertension and nausea, the company explained.
In June 2021, Actemra received Emergency Use Authorization (EUA) from the U.S. FDA, and is currently approved for use in 16 countries around the world for defined patients hospitalized with severe or critical COVID-19. In February 2022, the World Health Organization (WHO) prequalified Actemra for patients with severe or critical COVID-19, supporting access to care in low- and middle-income countries.
Following the emergence of the SARS-CoV-2 variant of concern, Omicron (B.1.1.529), in December 2021 WHO reported that interleukin-6 receptor blockers, such as Actemra, are expected to still be effective for managing patients with severe COVID-19.
Genentech and Roche are closely monitoring the Actemra supply situation and are seeing progress toward consistent, uninterrupted patient access to Actemra IV. The changing nature of the pandemic may continue to impact the availability of Actemra subcutaneous (SC) and IV formulations, the company said.