Gilead’s remdesivir becomes first EU-recommended therapy for COVID-19

pharmafile | June 26, 2020 | News story | Medical Communications, Sales and Marketing COVID-19, EU Gilead, remdesivir 

In a crucial step amidst the ongoing pandemic, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Gilead’s antiviral treatment remdesivir be awarded conditional marketing approval of COVID-19, the first for any treatment in Europe for the virus.

To meet prevalent unmet need, the therapy was recommended in patients at least 12 years old with pneumonia who require supplemental oxygen.

The drug was evaluated under an accelerated rolling review in partnership with the COVID-19 EMA pandemic task force (COVID-ETF) which began on 30 April, compiling data from non-clinical sources, manufacturing, safety and more prior to the filing of a marketing application submitted on 5 June.

Key data considered in this review showed that, in a study of 1,000 hospitalised patients, those treated with remdesivir recovered within around 11 days, compared to around 15 days for those receiving placebo. Those with severe disease made up 90% of the trial population, and in these patients recovery time was 12 days compared to 18 days with placebo, but no meaningful difference was observed in patients who were already receiving mechanical ventilation.

The committee ruled that remdesivir’s benefit/risk profile was overall positive in this patient population, to be administered via IV drip, beginning with a 200mg infusion on day one of treatment, followed by 100mg infusions daily for at least four days but no more than nine.   

However, it ruled that more data would be needed in order to pass a comprehensive approval and stipulated that further clinical data must be received by December this year. The European Commission was confirmed to be fast-tracking a conditional marketing approval to make the drug available for use in the EU in the coming week.

Matt Fellows

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