EMA recommends expanded use of remdesivir on compassionate grounds
The European Medicines Agency (EMA) has recommended for wider and expanded compassionate use of investigational drug remdesivir to treat coronavirus (COVID-19) patients for a shorter treatment duration especially those who are not on mechanical ventilation.The compassionate use recommendations now cover the treatment of hospitalised patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation).
European Medicines Agency had released its initial recommendations for providing remdesivir through compassionate use programs for patients who are ineligible for clinical trials in early April
The updated recommendations are based on preliminary results from the NIAID-ACTT study, which suggest a beneficial effect of remdesivir in the treatment of hospitalised patients with severe COVID-19. European Medicines Agency is currently evaluating these data in the context of the rolling review of remdesivir.
In addition, a treatment duration of 5 days has been introduced alongside the longer 10-day course, based on preliminary results from another study (GS-US-540-5773) suggesting that for patients not requiring mechanical ventilation or ECMO, the treatment course may be shortened from 10 to 5 days without any loss of efficacy. Patients who receive a 5-day treatment course but do not show clinical improvement will be eligible to continue receiving remdesivir for an additional 5 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.
Although remdesivir is not yet authorised for marketing in the European Union, these recommendations for compassionate use will help some patients with severe COVID-19 access the medicine while European Medicines Agency evaluates data on its benefits and risks. When the evaluation is complete, EMA will make a recommendation on whether or not remdesivir should receive a marketing authorisation.
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PDF iconsummary on compassionate use and the PDF iconconditions of use of remdesivir.
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