EMA Recommends Wider Compassionate Use of Remdesivir

The European Medicines Agency (EMA) has expanded its recommendations for compassionate use of Gilead Sciences’ remdesivir for patients with severe COVID-19.

The agency previously recommended the investigational drug only for patients undergoing invasive mechanical ventilation (DID, May 4).

It now recommends remdesivir for treating hospitalized patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or extracorporeal membrane oxygenation.

The agency said it based the new recommendation on the positive results from the National Institutes of Health’s clinical trial of the antiviral.

The EMA also called for a 5-day treatment course of remdesivir in addition to the longer 10-day course based on the results of Gilead’s own phase 3 trial (DID, April 30). Patients who do not show clinical progress after five days will be eligible to continue treatment for five more days.

The agency said that the shorter treatment duration would allow more patients to receive the medicine. — Jordan Williams