EMA Endorses Dexamethasone for Use in COVID-19 Patients on Oxygen Therapy

Based on its review of data from the RECOVERY study arm, the European Medicines Agency’s (EMA) human medicines committee (CHMP) is endorsing the use of dexamethasone in patients requiring oxygen therapy, EMA announced on Sept. 18, 2020. The corticosteroid dexamethasone, which has been authorized for use in the European Union for several decades, is used to treat inflammatory conditions.

According to EMA, “published data from the RECOVERY study show that, in patients on invasive mechanical ventilation, 29% of those treated with dexamethasone died within 28 days of starting dexamethasone treatment compared with 41% of patients receiving usual care, with a relative reduction of about 35%. In patients receiving oxygen without mechanical ventilation, the figures were 23% with dexamethasone and 26% with usual care, with a relative reduction of about 20%. No reduction in the risk of death occurred in patients who were not receiving oxygen therapy or mechanical ventilation. These results were supported by additional published data, including a meta-analysis conducted by the World Health Organization (WHO) which looked at data from seven clinical studies investigating the use of corticosteroids for the treatment of patients with COVID-19.”