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.

?Remdesivir would appear to meet or exceed standard for authorization under EUA, especially relative to other EUAs issued,? former FDA chief Scott Gottlieb said on Twitter an hour after Gilead?s press release.

After the data came out ? showing a 31% improvement in recovery time and a numerical, but not statistically significant, improvement in mortality for patients taking the drug ? The New York Times?reported that the FDA could authorize the drug that day. In a statement to Endpoints News, the FDA didn?t comment on the report but said the?agency has ?been engaged in sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate.?

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in an Oval Office press conference, said that the drug should become the ?new standard of care? for all Covid-19 clinical trials.

The EMA, however, has taken a harder stance on emergency authorizations for Covid-19. Four days after the FDA issued its letter allowing the use of antimalarials, the EMA issued a contrasting statement. They cautioned physicians against prescribing the drug outside their approved use or specific national protocols, citing both potential side effects and noting that, ?efficacy in treating COVID-19 is yet to be shown in studies. (Subsequent data on the drug have yet to clear the picture, although large randomized control studies are underway.)

The agency said they began the rolling review process for remdesivir in response to the data from the NIH trial, which was the largest randomized, placebo-controlled study to readout on a potential Covid-19 drug and the first to show efficacy. They said they will also consider other data around the drug, including a Chinese study published in The Lancet?yesterday that showed no significant efficacy for the drug but in a far smaller patient population.

The agency said they could not offer a timeline for when a decision would be made, although the process would be faster than the standard approval process for new drugs.

An emergency use authorization would potentially allow for more patients to access the drug. To date, the antiviral, originally developed for hepatitis C, ?has only been available to patients in clinical trials or under specific compassionate use or expanded access protocols.

In an open letter yesterday, Gilead CEO Daniel O?Day said the company has been ramping up supply of the drug since January and now have about 1.5 million doses on hand. That would be enough for 140,000 courses of 10-day treatment or 280,000 courses of 5-day treatments ? a Gilead study also released yesterday suggested both offered similar efficacy.

?On the supply side, we are working to build a global consortium of pharmaceutical and chemical manufacturers to expand global capacity and production,? he said. ?In the event of regulatory action, we are in discussions with various groups about how we might bring remdesivir to the developing world.?

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Social image: Anthony Fauci and Deborah Birx, AP Images

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