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EMA recommends expanded compassionate use of Gilead’s remdesivir

New criteria includes a wider range of severely ill COVID-19 patients

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The European Medicines Agency (EMA) has recommended expanding the use of Gilead’s investigational antiviral drug remdesivir, to include patients not on mechanical ventilation.

The EMA has already begun a rolling review of remdesivir, but said at the time that it couldn’t put a time frame on the possible approval of the drug as a treatment for COVID-19. However, it maintained the ongoing review should allow it make a decision as soon as possible.

Meanwhile, the agency’s Committee for Medicinal Products for Human Use (CHMP) has turned its focus on the compassionate use criteria for the drug, to make remdesivir as widely available to as many severely ill COVID-19 as possible while it evaluates the data for market authorisation of the drug.

The new recommendations include use in the treatment of patients hospitalised with the disease who require supplemental oxygen, non-invasive ventilation, high-flow oxygen device or ECMO (extracorporeal membrane oxygenation).

In addition to the new recommendation criteria, the EMA has introduced a new five-day treatment course alongside the longer ten-day treatment course of remdesivir. This decision is based on initial findings from the GS-US-540-5773 study, which suggested that for patients who did not require mechanical ventilation or ECMO, a five-day course can be administered without a reduction in efficacy.

Earlier this month, the US Food and Drug Administration (FDA) granted remdesivir emergency use authorisation after the drug showed preliminary efficacy in clinical testing.

That data, from the the National Institute of Allergy and Infectious Diseases (NIAID)-led ACTT trial, demonstrated that remdesivir was associated with a 31% faster recovery time compared to those who were not given the drug.

Overall, those patients treated with the experimental drug recovered after 11 days, compared to 15 days for those on the placebo arm. The results also showed a trend towards improved survival, with the remdesitvir-treatment arm having a mortality rate of 8% compared to 11.6% for those receiving a placebo.

Since then, Japan has also authorised the use of the drug under the brand name Veklury to treat severely ill coronavirus patients.

Article by
PMGroup

12th May 2020

From: Research

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