FDA Gives EUA for Genentech's Actemra for COVID-19 Hospitalizations

Genentech’s COVID-19 drug therapy Actemra (tocilizumab) is the latest to receive an emergency use authorization, FDA announced Thursday.

The EUA makes the drug available to treat hospitalized adults and children two years and older receiving systemic corticosteroids and supplemental oxygen, ventilation, or extracorporeal membrane oxygenation. The authorization does not extend to outpatient settings.

“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 public statement. “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.”

Data from clinical trials of individuals hospitalized for COVID-19 indicate that Acterma in conjunction with routine care decreased both the risk of death, duration in hospital, and the likelihood of being placed on ventilators.

Delivered via intravenous infusion, tocilizumab is a monoclonal anti-inflammatory antibody that targets the interleukin-6 receptor. The COVID-19 therapy does not actively target SARS-COV-2. It is currently approved for the treatment of multiple inflammatory diseases (e.g., rheumatoid arthritis).

Four clinical trials provided the data necessary for FDA emergency use authorization: one randomized, controlled, open-label, platform trial and three randomized, double-blind, placebo-controlled trials. Two trials, in particular, provided the most important scientific evidence:

In the RECOVERY trial, 4,116 hospitalized patients with severe COVID-19 pneumonia were randomized to receive either Actemra in addition to usual care (2,022 patients) or usual care alone (2,094 patients). The primary endpoint evaluated death through 28 days of follow-up, and the results of the primary analysis were statistically significant. The probabilities of death by day 28 were estimated to be 30.7% for patients receiving Actemra and 34.9% for patients receiving usual care alone. The median time to hospital discharge was 19 days for patients receiving Actemra and more than 28 days for patients receiving usual care alone.

In the EMPACTA trial, 389 hospitalized patients with COVID-19 pneumonia were randomized to receive Actemra (249 patients) or placebo (128 patients). The primary endpoint evaluated the need for mechanical ventilation or death through 28 days of follow-up. For patients receiving Actemra, there was an observed reduction in progression to mechanical ventilation or death compared to patients who received placebo, with the primary analysis results being statistically significant. The proportion of patients who required mechanical ventilation or died by day 28 was estimated to be 12.0% for patients receiving Actemra and 19.3% for patients receiving placebo.

Genentech is a biotechnology company and a member of the Roche Group.

“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 stated publicly. “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.”