EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory support

News 24/07/2020

EMA 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. This part of the study looked into the effects of adding dexamethasone to usual care in adults receiving invasive ventilation, those given oxygen (e.g. through a mask) or those receiving no oxygen. Invasive ventilation involves use of a machine to push air through a tube inserted into the patient’s airway.

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% in patients on invasive mechanical ventilation1;
  • reduced mortality by about 20% in patients receiving oxygen without invasive ventilation2;
  • 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 will communicate further when the review is complete.

More about the medicine

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.

More about the procedure

The review of dexamethasone has been initiated at the request of the EMA Executive Director under Article 5(3) of Regulation 726/2004 following preliminary discussion with the COVID-19 EMA pandemic task force (COVID-ETF), which brings together experts from across the European medicines regulatory network to advise on the development, authorisation and safety monitoring of medicines and vaccines for COVID-19.

The review is being carried out by EMA’s Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, 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.

1 Update on 02/09/2020: 29% of patients receiving mechanical ventilation and treated with dexamethasone died compared with 41% of patients receiving usual care - see EMA receives application for marketing authorisation of Dexamethasone Taw for COVID-19

Update on 02/09/2020: In patients receiving oxygen, the figures were 23% with dexamethasone and 26% with usual care - see EMA receives application for marketing authorisation of Dexamethasone Taw for COVID-19

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