EMA, WHO announce updates for steroids in COVID

Regulatory NewsRegulatory News
| 02 September 2020 | By Kari Oakes 

The European Medicines Agency (EMA) is reviewing the use of dexamethasone to treat hospitalized patients with COVID-19. The agency announced today that it is considering an application for marketing authorization submitted by Taw Pharma; the review is following an accelerated assessment timetable.
EMA, in announcing that its human medicines committee (CHMP) will review Taw’s application, cited results from the RECOVERY trial that were published in July 2020. The RECOVERY results published then showed an absolute risk reduction of 12% in deaths for mechanically ventilated COVID-19 patients who were treated with dexamethasone, compared with mechanically ventilated patients receiving usual care. The dexamethasone-attributed absolute reduction in risk of death was 3% for patients with COVID-19 who required supplemental oxygen but who were not mechanically ventilated compared with those receiving usual care. No benefit was seen for hospitalized patients who did not need ventilatory support.
“Should the available data show that the benefits of Dexamethasone Taw outweigh its risks in the treatment of hospitalised adults with COVID‑19, EMA will issue a positive recommendation on the medicine’s new use in patients with COVID-19. The agency will then liaise with the European Commission to fast-track the authorization,” said EMA in announcing the receipt of Taw’s application.
The World Health Organization (WHO) today announced strong support for the use of steroids such as dexamethasone for severe or critical coronavirus infections. The “living guidance” document includes recommendations for systemic corticosteroids (rather than no corticosteroids) to treat patients with severe or critical COVID-19. This recommendation from WHO comes with a strong recommendation, based on evidence of moderate certainty.
The guidance also recommends that corticosteroids not be used in patients with COVID-19 that is not severe. This recommendation is “conditional” and based on low-certainty evidence.
WHO’s analysis and decision-making was completed in collaboration with the Magic Evidence Ecosystem Foundation (MAGIC), a nonprofit that provided methodologic support in formulating the evidence-based guidance.

WHO partnered with leaders of seven clinical trials of the use of corticosteroids in COVID-19 on a prospective meta-analysis of randomized trials to formulate supported the guidance. This meta-analysis, whose methods and rationale are fully laid out in the guidance, found a “probable” reduction of the risk of 28-day mortality in critically and severely ill COVID-19 patients (relative risk 0.80).

On the other hand, WHO’s analysis found a probable increased risk of death at 28 days for patients with non-severe COVID-19 who received steroids (RR 1.22).
Unlike EMA’s ongoing assessment of dexamethasone, the WHO analysis also included hydrocortisone as a COVID-19 therapy, finding benefits similar to dexamethasone. Results of the meta-analysis were published today in JAMA, together with the results of three other clinical trials of corticosteroids in COVID-19 that were stopped early when the RECOVERY trial’s dexamethasone results were published.
In laying out its thinking on the use of steroids for COVID-19, WHO did note that some panel members “argued that the trials evaluating systemic corticosteroids for COVID-19 reported limited information regarding potential harm.” However, at its two meetings, the panel that reviewed evidence and formulated the guidance also observed that “In contrast with new agents proposed for COVID-19, clinicians have a vast experience of systemic corticosteroids and the panel was reassured by their overall safety profile.”


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