www.fdanews.com/articles/205657-ema-recommends-roches-roactemra-for-adults-with-severe-covid-19
EMA Recommends Roche’s RoActemra for Adults with Severe COVID-19
December 7, 2021
The European Medicines Agency (EMA) has endorsed Roche’s arthritis therapy RoActemra (tocilizumab) — known as Actemra in the U.S. — for treating adults hospitalized with severe COVID-19.
The drug, recommended for patients who require corticosteroids treatment and supplemental oxygen, works by inhibiting the body’s inflammatory reaction to COVID-19, called a cytokine storm.
The EMA’s human medicines committee assessed data from 4,116 hospitalized adults showing that patients given RoActemra plus standard of care had a reduced risk of death vs. those given standard of care alone.
In July, the World Health Organization (WHO) signed off on administering the drug plus corticosteroids for treating severe COVID-19.