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The European Medicines Agency (EMA) has endorsed the use of dexamethasone in patients with COVID-19 on oxygen or mechanical ventilation, following a review of the RECOVERY study by the agency’s Committee for Medicinal Products for Human Use.
Dexamethasone can be considered a treatment option for adults and adolescents (12 years or older, weighing at least 40 kg) with SARS-CoV-2 infection who require supplemental oxygen therapy, the EMA said.
Dexamethasone can be given by mouth, injection, or infusion. In all cases, the recommended dose in adults and adolescents is 6 mg once daily for up to 10 days.
As part of the RECOVERY study, patients hospitalized with COVID-19 were randomly allocated to oral or intravenous dexamethasone (6 mg once daily) for up to 10 days or to usual care alone.
Overall, 482 patients (22.9%) who received dexamethasone and 1110 patients (25.7%) who received usual care died within 28 days after randomization.
Preliminary results indicate that, compared with usual care, dexamethasone reduced mortality by about 35% in patients on invasive mechanical ventilation and by about 20% in patients receiving oxygen without invasive ventilation.
No reduction in the risk for death was seen in patients who were not receiving oxygen therapy or mechanical ventilation.
The results were published in the New England Journal of Medicine in July.
“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,” the EMA said in a statement announcing the endorsement of dexamethasone for severe COVID-19.
The agency said that companies that market dexamethasone medicines can submit an application to national medicines agencies or to the EMA to request that this new use be added to their product’s license.
The proposed changes to the dexamethasone product information for patients and healthcare professionals are available online.