EMA evaluating dexamethasone for COVID-19 as WHO meta-analysis of three steroids reiterates benefit

EMA includes RECOVERY data in review of dexamethasone MAA
EMA said it has begun evaluating dexamethasone from Taw Pharma to treat hospitalized COVID-19 patients, and is considering CHMP’s review of the U.K’s RECOVERY trial data in its evaluation of the MAA. In June, data from the master protocol study’s dexamethasone arm revealed that the steroid reduced mortality, with the greatest effect seen in the sickest patients. The U.K. approved dexamethasone to treat hospitalized COVID-19 patients who require oxygen the same day RECOVERY’s results were released (see “Steroid Shows Survival Benefit in COVID-19”).

WHO meta-analysis reinforces dexamethasone benefit
The WHO Rapid Evidence Appraisal for COVID-19 Therapies (REACT) Working Group published a meta-analysis in the The Journal of the American Medical Association on Wednesday showing corticosteroids are associated with less death. The analysis covered 1,703 COVID-19 patients requiring respiratory support in seven trials: three, including RECOVERY, evaluating dexamethasone, three studying hydrocortisone and one for methylprednisolone. Subgroup analyses based on steroid showed a statistically significant survival benefit for dexamethasone, but not hydrocortisone or methylprednisolone. ...