After NIH trial, EMA begins rolling review for remdesivir, setting up potential authorizations in US and Europe
A day after the NIH released positive results from their trial testing remdesivir in Covid-19, the EMA has announced the start of a rolling review process for the drug. With an FDA decision expected to arrive in the coming days, the news sets the stage for the Gilead antiviral to become the standard-of-care for the deadly virus in both the US and Europe.
Yesterday morning, Gilead issued a press release that the NIH would soon issue positive data on a much-anticipated trial testing their antiviral remdesivir against a placebo in Covid-19 patients. The news prompted immediate speculation of whether an emergency use authorization (EUA) — a clearance from the FDA that bypasses the lengthy approval process — would follow. The agency had controversially issued an EUA for the antimalarials hydroxychloroquine and chloroquine in March, a decision that was taken without the support of a randomized controlled trial.
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