The Food and Drug Administration granted emergency approval to Roche’s Actemra (tocilizumab) to boost outcomes among hospitalized COVID-19 patients receiving oxygen and steroid medications.
Data from clinical trials among over 5,600 hospitalized patients indicated infusions, in addition to routine care, cut patients’ length of hospital stay and reduced the risk of death and ventilation after 28 days of follow-up.
“Today’s action demonstrates the FDA’s commitment to making new therapies available through every stage of the global COVID-19 pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research in a statement posted late Thursday. “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.”
The antibody drug doesn’t target the virus but works to alleviate inflammation by blocking the interleukin-6 receptor involved in the immune response. It was authorized to treat certain hospitalized COVID-19 patients aged 2 and up. Actemra is already approved for other inflammatory diseases, like rheumatoid arthritis.
The FDA has cleared several antibody drugs for COVID-19 but there has been low demand because of the hurdles of delivering them via IV at hospitals or clinics. Health officials have emphasized the need to develop more pill-based drugs for COVID-19.
The agency cited data from four clinical trials; the open-label RECOVERY trial involving some 4,116 patients with severe COVID-19 pneumonia suggested a reduction in risk of death after 28 days with odds of 30.7% in the treatment group compared to 34.9% for patients receiving usual care. The drug also cut the length of hospital stay by at least nine days (19 vs. over 28). Another trial, the double-blinded EMPACTA study, among 389 hospitalized patients with COVID-19 pneumonia revealed 12% of the treatment group needed mechanical ventilation or died after 28 days, compared with 19.3% of patients taking placebo.
“Even with the availability of vaccines and declines in deaths from COVID-19 in various parts of the world, we continue to see new hospitalisations from severe forms of the disease,” Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development, said in a statement. “We are pleased that Actemra/RoActemra is now authorised as an option that may help improve outcomes for adults and children hospitalised with COVID-19 in the United States.”