FDA grants priority review for tocilizumab to treat patients hospitalized with COVID-19
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The FDA has granted priority review for intravenous tocilizumab to treat adults hospitalized with COVID-19 who are receiving systemic corticosteroids and require supplemental oxygen, mechanical ventilation or extracorporeal membrane oxygenation.
A final FDA decision on approval is expected in the second half of the year, according to a press release issued by Roche. Tocilizumab (Actemra, Genentech) is currently under an emergency use authorization for this indication in adults and children aged 2 years and older.
“The high rate of unvaccinated people will continue to put a strain on hospitals and health care systems around the world, furthering the need for effective treatments for patients hospitalized with COVID-19,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Roche, said in the release. “More than 1 million people with severe or critical COVID-19 have already been treated with Actemra/RoActemra worldwide, demonstrating the important role of this medicine in the fight against the pandemic.”
Roche, which owns Genentech, submitted its supplemental Biologics License Application to the FDA based on results from four randomized, controlled trials that examined tocilizumab for COVID-19 in 5,500 hospitalized patients. According to Roche, data from these studies — RECOVERY, EMPACTA, COVACTA and REMDACTA — suggest that tocilizumab may improve outcomes in patients who are receiving corticosteroids and require supplemental oxygen or breathing support. These studies also formed the basis of the FDA’s EUA for the drug.
In the RECOVERY trial, 4,116 hospitalized patients with severe COVID-19 pneumonia were randomized to receive either tocilizumab plus standard care or standard care alone. The primary endpoint was death through 28 days of follow-up.
In its EUA announcement in June, the FDA stated that “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. The median time to hospital discharge was 19 days in the tocilizumab group, compared with more than 28 days in the standard care group.
Meanwhile, the EMPACTA trial randomized 389 hospitalized patients with COVID-19 pneumonia to receive either tocilizumab or standard care. Supplemental data from this study demonstrated a lower risk for progression to mechanical ventilation or death by day 28 in hospitalized patients who received tocilizumab — 12% vs. 19.3%.
Tocilizumab is currently approved for the treatment of defined patients hospitalized with severe or critical COVID-19 in 16 countries. The WHO prequalified the drug for patients with severe or critical COVID-19 in February.
Roche stated it is also working with health authorities to improve availability of its COVID-19 treatments around the world, including a program offering tocilizumab at cost to the WHO and partners of the Access to COVID-19 Tools Accelerator (ACT-A) Initiative. According to Roche, this program builds on the “significant portion of Actemra/RoActemra supply” that the company has provided to upper-middle and lower-middle income nations since the beginning of the pandemic. The company is also implementing an international differentiated pricing strategy “specifically designed to address needs during this pandemic and improve affordability.”
“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/RoActemra, are expected to still be effective for managing patients with severe COVID-19,” read the Roche press release, in part. “Roche stands together with society, governments, health care providers and all those working towards the common goal of overcoming the COVID-19 pandemic.”
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