CHMP Recommends Expansion of Compassionate Use of Remdesivir

The European Medicines Agency’s (EMA’s) Committee for Human Medicinal Products (CHMP) has issued a recommendation that the compassionate use of remdesivir be expanded in the treatment of more patients with severe COVID-19 symptoms. CHMP’s recommendation has been published in a May 11, 2020 press release on EMA’s website.

As a result of the recommendation, in addition to patients undergoing invasive mechanical ventilation, patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices, or extracorporeal membrane oxygenation (ECMO), will also be incorporated into the compassionate use scheme. The recommendation to expand the compassionate use has been made based on preliminary results from the NIAID-ACTT study, suggesting a beneficial effect with treatment of remdesivir in severe COVID-19 cases.

Furthermore, a shorter treatment duration of five days has been introduced with the new recommendation based on preliminary results from another study (GS-US-540-5773), which have suggested that a shorter duration of treatment may be suitably effective in patients not requiring mechanical ventilation or ECMO. In patients that have been given a treatment course of five-days but have not shown clinical improvement, it will be possible for a continuation of treatment to be administered for another five days.

EMA is continually evaluating data on remdesivir on a rolling basis. Although the treatment is not yet authorized for marketing in the European Union, through the new recommendations, more patients will have access to the treatment while EMA evaluates the data on benefits and risks. 

Source: EMA