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The agency is reviewing an application for Dexamethasone Taw for treating adult patients with COVID-19.
The European Medicines Agency (EMA) announced on Sept. 2, 2020 that it is reviewing an application for a treatment for hospitalized adults with COVID-19. The agency’s human medicines committee (CHMP) will be evaluating Taw Pharma’s Dexamethasone Taw under an accelerated assessment timetable, which will allow the committee to issue an opinion in the shortest possible timeframe.
According to EMA, results published from the RECOVERY trial in July 2020 “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% of those treated with dexamethasone died within 28 days of starting dexamethasone treatment compared with 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. No reductions in death occurred in patients who were not receiving oxygen therapy or mechanical ventilation,” EMA said in a press release. CHMP is reviewing the results of the RECOVERY trial and will consider the results in their evaluation of the authorization application for Dexamethasone Taw.
The agency stated it will issue a positive recommendation if data show that the benefits of Dexamethasone Taw outweigh the risks in treatment of hospitalized adults with COVID-19. EMA plans to work with the European Commission to fast-track the authorization if the agency issues a positive recommendation.
Dexamethasone drugs are authorized in Europe to treat “various conditions on the basis of their anti-inflammatory properties,” according to EMA, and the current application does not impact other dexamethasone medicines.