EMA begins review of Dexamethasone Taw for COVID-19

The European Medicines Agency (EMA) has begun evaluating an application for the authorisation of Dexamethasone Taw for treating adults hospitalised with COVID-19.

The application, from Taw Pharma, will be evaluated by EMA’s human medicines committee (CHMP) according to an accelerated assessment timetable, allowing the committee to issue an opinion on the benefits and risks of the drug within the shortest possible timeframe.

Results from the UK's RECOVERY trial found that in patients receiving hospital treatment for severe respiratory complications of COVID-19 there were fewer deaths in those treated with dexamethasone.

In patients on invasive mechanical ventilation, 29% given dexamethasone died within 28 days of starting dexamethasone treatment versus 41% of patients receiving usual care, a relative reduction of about 35%.

In patients receiving oxygen without mechanical ventilation, the figures were 23% with dexamethasone and 26% with usual care.

Before receiving this application, the CHMP had started reviewing the results of the RECOVERY trial in order to provide an opinion on the use of dexamethasone medicines for COVID-19. The outcome of this review will be considered in the evaluation of Dexamethasone Taw, the agency noted.

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 and then liaise with the European Commission to fast-track the authorisation.