EMA Recommends Expanded Remdesivir Compassionate Use Scheme

Country: NETHERLANDS | Region: EUROPE | Type: Regulation | Keywords: #chmp #compassionateuse #covid-19 #ema #gilead #remdesivir

PRICENTRIC BRIEF:

  • The European Medicines Agency’s (EMA) human medicines committee, CHMP has recommended expanding the compassionate use scheme for Gilead’s remdesivir to allow more patients with severe COVID-19 infection to be treated with the antiviral
  • On top of patients who are undergoing invasive medical ventilation, the compassionate use recommendation from EMA now covers the treatment of hospitalized patients in need of supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation)
  • Moreover, a treatment duration of 5 days has been introduced alongside the longer 10-day course, based on preliminary results from GS-US-540-5773, another study in which it was suggested that for patients not requiring mechanical ventilation or ECMO treatment course may be shortened to 5 days from 10 without any negative impact on efficacy

THE DETAILS

AMSTERDAM, The Netherlands – The European Medicines Agency’s (EMA) human medicines committee, CHMP has recommended expanding the compassionate use scheme for Gilead’s remdesivir to allow more patients with severe COVID-19 infection to be treated with the antiviral.

On top of patients who are undergoing invasive medical ventilation, the compassionate use recommendation from EMA now covers the treatment of hospitalized patients in need of supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation).

EMA was able to issue this updated recommendation due to positive results from the NIAID-ACTT study of remdesivir in patients hospitalized with severe COVID-19.

Moreover, a treatment duration of 5 days has been introduced alongside the longer 10-day course, based on preliminary results from GS-US-540-5773, another study in which it was suggested that for patients not requiring mechanical ventilation or ECMO treatment course may be shortened to 5 days from 10 without any negative impact on efficacy.

As such, patients who receive 5-days’ worth of remdesivir but show no clinical improvement will be permitted to continue their treatment for another 5 days. Shortening treatment duration is allowing for more people to take remdesivir.

Currently, EMA is evaluating these data within the context of a rolling review of remdesivir, which has not yet been authorized for marketing in the European Union (EU). The compassionate use scheme is allowing for the drug to be made available while EMA evaluates its benefits and risks.

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