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Remdesivir: EMA recommends wider compassionate use

Credit: CDC/ C.S. Goldsmith and A. Tamin

Regulatory NewsRegulatory News
Posted 11 May 2020 | By Michael Mezher 

Remdesivir: EMA recommends wider compassionate use

The European Medicines Agency (EMA) on Monday recommended expanding compassionate use programs for Gilead Sciences’ investigational drug remdesivir to treat coronavirus disease (COVID-19) patients who are not on mechanical ventilation and to allow for a shorter treatment duration based on the results of two recent clinical studies.
 
In early April, EMA released its initial recommendations for providing remdesivir through compassionate use programs for patients who are ineligible for clinical trials. (RELATED: EMA advises on compassionate use programs for remdesivir, Regulatory Focus 3 April 2020).
 
Now, EMA says that compassionate use programs for remdesivir should be expanded to include hospitalized patients who need supplemental oxygen, non-invasive high-flow oxygen devices or extracorporeal membrane oxygenation (ECMO). EMA says the recommendation is based on the preliminary results from a US study of remdesivir run by the National Institutes of Health that found patients treated with remdesivir had a 31% shorter time to recovery than patients taking a placebo.
 
EMA is also recommending a five-day treatment duration in addition to a ten-day course based on the results of a Gilead study that found a shorter treatment course did not result in loss of efficacy for patients who were not on ventilators or ECMO. EMA notes that patients on the five-day course who do not show signs of improvement may continue to receive remdesivir for an additional five days.
 
“The option to shorten treatment duration also means that more patients may be able to receive the medicine, which is in very high demand worldwide,” EMA says.
 
The revised recommendations for compassionate use come after EMA began a rolling review of remdesivir earlier this month and after the US Food and Drug Administration (FDA) authorized the drug for emergency use. (RELATED: EMA kicks off rolling review of Gilead’s remdesivir, Regulatory Focus, 1 May 2020; FDA authorizes Gilead’s remdesivir for emergency use, Regulatory Focus 1 May 2020).
 
EMA

 

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