FDA Authorizes “Emergency” Use of Gilead’s Remdesivir for Severe COVID-19

Xconomy National — 

Regulators on Friday afternoon granted emergency authorization for the Gilead Sciences drug remdesivir as a treatment for patients hospitalized with severe COVID-19 infections.

The decision makes the antiviral drug, which is delivered via intravenous infusion, the second drug to receive authorization under the FDA’s emergency guidelines for use against the novel coronavirus. The first was issued March 28 for the use of antimalarial drugs chloroquine phosphate and hydroxychloroquine sulfate, a decision made based on limited in-vitro and anecdotal clinical data.

In a letter notifying Foster City, CA-based Gilead (NASDAQ: GILD) the drug had received emergency authorization, the FDA said the decision was based on its review of preliminary data from a study conducted by the National Institute of Allergy and Infectious Diseases (NIAID) and an open-label trial conducted by Gilead that evaluated 10-day and five-day courses of the drug, data from which were made public this week. Authorization is not a typical drug approval. Drugs OK’d for use under such guidelines as a COVID-19 treatment are permitted only as long as the circumstances that led to the emergency persist.

The NIAID study, which was randomized and double-blinded, revealed that patients who received the drug recovered at a faster rate than those who given a placebo. The Gilead study showed little difference in patient outcomes between the 10-day course, which is what patients in other studies have been receiving, and one half that length. That suggests patients could achieve similar outcomes from less of the drug, which would mean that the current supply of the drug could reach more patients than initially believed.

Earlier this month Gilead CEO Daniel O’Day said the biotech would donate its existing supply of the drug through early summer, which amounts to 140,000 courses of 10-day treatment. Optimal dosing remains unknown, but the emergency authorization guidelines suggest 10-day courses for the most severe patients, those requiring invasive mechanical ventilation and/or extracorporeal membrane oxygenation, and the five-day duration for patients who don’t require such intervention. Patients that don’t improve after the five-day course may extend their treatment for up to 10 days total.

The authorization order recommends that healthcare providers look out for signs of liver inflammation or damage and infusion-related reactions, including low blood pressure, nausea, vomiting, sweating, and shivering.

So far, doses of the drug have been deployed for compassionate use, expanded access, and clinical trials; now the medicine will also be used for broader distribution.

That distribution, Gilead said, will be controlled by the US government, which will prioritize its use in hospitals in cities most heavily impacted by COVID-19. Gilead says it is working with the government on the logistics of remdesivir distribution; it’s not yet clear when the company will begin shipping the drug.

Gilead has been working since January to ramp up manufacturing of the drug in the event it proved effective.

“As additional raw materials come available we’ll have an exponential increase in supply toward the latter half of this year,” with a goal of having enough to treat more than 1 million patients by year’s end, O’Day said on a Thursday conference call.

The FDA issued the authorization after the public markets closed Friday. Gilead’s stock price closed at $79.95. Earlier in the week it closed at $84 per share, the highest the stock has ever traded.

According to O’Day’s comments on Thursday, Gilead is also working toward earning approval of the drug: “We feel the data supports that, and an EUA, therefore, is a step toward a more formalized approval… It’s a step-wise approach which allows us to immediately address the humanitarian need while still pursuing all the aspects of a normal approval, which we are doing with the FDA.”