Based partly on results of clinical trials for patients from underrepresented racial and ethnic groups, the Food and Drug Administration (FDA) yesterday approved the use of Actemra for hospitalized patients suffering from severe COVID-19 symptoms, according to a press release by the medication’s maker, Roche.
The FDA’s approval comes at a time when other monoclonal antibodies appear to be losing their effectiveness against new subvariants of omicron, such as BQ.1 and BQ.1.1., which now account for nearly 70% of cases in the U.S., according to the Centers for Disease Control and Prevention.
The FDA rescinded emergency use authorization last month for the Eli Lilly antibody treatment, bebtelovimab, because of ineffectiveness against the new subvariants. The FDA said in a press release at the time that it pulled the EUA because bebtelovimab is not expected to neutralize omicron subvariants BQ.1 and BQ.1.1.
The FDA gave Actemra EUA in June 2021 to treat severe cases of COVID-19, and Roche yesterday touted Actemra as “the first FDA-approved monoclonal antibody to treat COVID-19.” The company added that “no new warnings and precautions related to Actemra in COVID-19 studies have been identified.”
Levi Garraway, M.D., Ph.D., Roche’s CMO and head of global product development, said in the press release that “with new variants emerging, FDA-approved treatments including Actemra remain essential to the continued fight against COVID-19. Actemra is the first FDA-approved monoclonal antibody for treating patients with severe COVID-19, providing an important option for hospitalized patients and their healthcare providers who continue to be on the frontlines treating COVID-19.”
Actemra first received FDA approval in 2010 as an anti-inflammatory medication for rheumatoid arthritis.
The FDA’s approval for Actemra resulted from findings in four randomized controlled studies involving over 5,500 patients that included the Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial at the University of Oxford.
Data also came from three Roche global trials: EMPACTA, COVACTA and REMDACTA.
EMPACTA (Evaluating Minority Patients with Actemra) conducted a phase 3 clinical trial of Actemra in 2020 in which 85% of the patients involved represented minority racial and ethnic groups, “with significant representation of Native American and Black populations,” according to the company.
“The FDA approval follows the FDA’s [EAU] for Actemra in hospitalized adults and children (ages 2 and older) with COVID-19, which was granted in June 2021,” Roche states in its press release. “The use of Actemra to treat hospitalized people ages 2 to less than 18 years old is not FDA approved, however the EUA for this age group currently remains in place after the FDA approval for hospitalized adult patients.”
The company adds that more than a million people worldwide who’ve been hospitalized with severe COVID-19 symptoms have been treated with Actemra, and it's gotten approval for such use in more than 30 countries.
“In the United States, this is the seventh FDA approved indication for Actemra since the medicine was launched in 2010,” the company states.