EMA Starts Review of Dexamethasone as COVID-19 Treatment

The European Medicines Agency (EMA) has announced in a July 24, 2020 press release that it has started a review of dexamethasone as a treatment for adults with COVID-19 who require respiratory support and have been admitted to hospital.

Specifically, the regulatory agency is reviewing data from the RECOVERY study arm that looked at the effects of adding dexamethasone to usual care in adults receiving invasive ventilation, in those receiving oxygen (e.g., through a mask), or in those receiving no oxygen. In the study, any deaths that happened 28 days after starting dexamethasone treatment were recorded and preliminary results indicate that dexamethasone reduced mortality in patients receiving respiratory support compared with usual care.

With this review, EMA hopes to provide an opinion on the RECOVERY study and also on the potential use of dexamethasone for the treatment of adults with COVID-19. More information will be presented by the agency when available.

Source: EMA