European Medicines Agency endorses use of dexamethasone in COVID-19 patients on supplemental oxygen therapy or on mechanical ventilation

The European Medicines Agency EMA’s Committee for Medicinal Products for Human Use (CMPH) has reviewed the results of the RECOVERY study* on the use of the corticosteroid medicine dexamethasone in the treatment of hospitalised patients with COVID-19.

According to the assessment, dexamethasone treatment is useful in COVID-19 patients who are adults or over 12 years of age, weigh at least 40 kg and in whose treatment supplemental oxygen therapy is needed. Dexamethasone treatment can be implemented orally or intravenously. The dosage is 6 mg once a day for ten days.

In the RECOVERY study, mortality among COVID-19 patients who were on a ventilator and received dexamethasone treatment was 29% after 28 days of treatment, while mortality among corresponding patients who did not receive dexamethasone was 41%. Mortality among COVID-19 patients who needed only supplemental oxygen also declined with dexamethasone treatment. In the dexamethasone group, mortality was 23% among patients who were given supplemental oxygen, while it was 26% among those who were not given dexamethasone. Dexamethasone did not reduce mortality in COVID-19 patients who were hospitalised but did not require supplemental oxygen therapy (or a ventilator).

In addition, the World Health Organisation WHO conducted a meta-analysis of seven studies in which COVID-19 patients had been treated with corticosteroids. The results of the meta-analysis support the findings of the RECOVERY study and the benefits of corticosteroids in the treatment of COVID-19 patients.

The corticosteroid medicine dexamethasone is used to reduce inflammation and the body's immune responses in autoimmune diseases, allergies and cancer treatment. In Finland, the availability of dexamethasone products has been secured with fixed-term restrictions on their sale and release for consumption (Fimea’s online news article on 18 August 2020, in Finnish https://www.fimea.fi/-/parasetamolia-tai-deksametasonia-sisaltavien-laakkeiden-myyntia-rajoitetaan-saatavuuden-ja-riittavyyden-varmistamiseksi ).

The holders of dexamethasone marketing authorisations can apply for the new therapeutic indication for their authorised products by submitting an application to the national medicines agency or, in the case of new products, also apply to EMA through the centralised procedure.

Read more about the recommendation of the Committee for Medicinal Products for Human Use:

EMA’s Committee for Medicinal Products for Human Use (CHMP): Possible changes to the summary of product characteristics and to the package leaflet (pdf)

EMA’s press release on 18 September 2020

* The RECOVERY Collaborative Group: Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report. NEJM, July 17, 2020, DOI: 10.1056/NEJMoa2021436