EMA initiates review of dexamethasone for treating COVID-19

The European Medicines Agency (EMA) has announced it is reviewing results from the RECOVERY study arm that involved the use of dexamethasone in the treatment of patients with COVID-19 admitted to hospital.

According to the EMA, this part of the study looked into the effects of adding dexamethasone to usual care in adults receiving invasive ventilation, those given oxygen (eg, through a mask) or those receiving no oxygen. 

Dexamethasone is a corticosteroid medicine that has been authorised in the EU by national medicines authorities and has been available for several decades. It can be used by mouth and by injection for treating a range of inflammatory conditions and for reducing the body’s immune response in the treatment of allergies and autoimmune diseases. It is also used with cancer medicines to treat certain cancers and to prevent vomiting.

The RECOVERY study recorded deaths during 28 days after starting dexamethasone treatment. Preliminary results indicate that, compared with usual care, dexamethasone:

• reduced mortality by about 35 percent in patients on invasive mechanical ventilation
• reduced mortality by about 20 percent in patients receiving oxygen without invasive ventilation
• did not reduce death in patients who were not receiving oxygen therapy.

The review aims to provide an opinion on the results of the RECOVERY study and in particular the potential use of dexamethasone for the treatment of adults with COVID-19.

EMA says it will communicate further information when the review is complete. The review is being carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP), which will issue a scientific opinion within the shortest possible timeframe. The scientific opinion is then published and can be taken into account by EU member states when evaluating medicines.