(RxWiki News) A new medication to treat COVID-19 has earned emergency approval from the US Food and Drug Administration (FDA).
This drug is called Actemra (tocilizumab). The FDA issued an emergency use authorization (EUA) for Actemra to be used in hospitalized adults and children older than 2 with serious COVID-19 cases.
In this case, "serious" means the patient is receiving systemic corticosteroids and requires oxygen or is on a ventilator.
“Today’s action demonstrates the FDA’s commitment to making new therapies available through every stage of the global COVID-19 pandemic,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a press release. “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.”
Actemra doesn't target the COVID-19 virus directly. Instead, it blocks the interleukin-6 receptor, which results in reduced inflammation.
While the FDA did not approve Actemra to treat COVID-19 directly, it did approve this drug to be used in some patients who have been hospitalized with COVID-19. Actemra has received prior FDA approval to treat several inflammatory diseases, including rheumatoid arthritis.
The FDA issued the EUA for Actemra based on the results of four clinical trials of this intravenous drug. Combined with routine care for COVID-19, Actemra appeared to reduce the risk of dying within one month of getting COVID-19 and lower the amount of time spent in the hospital, the FDA noted.
Side effects of Actemra included nausea, diarrhea, constipation, insomnia, anxiety and high blood pressure.
The FDA issued the EUA for Actemra to Genentech Inc.