The Food and Drug Administration late Friday expanded its emergency use authorization for Gilead Sciences ’ Covid-19 therapeutic remdesivir, saying the drug can now be used in any patient hospitalized for Covid-19.
The agency previously had authorized the unapproved treatment for only the sickest Covid-19 patients. The FDA said it now believes that the drug “may be effective” in all hospitalized Covid-19 patients, and that the potential benefits outweigh the known and potential risks.
The FDA’s move came after a week of political turmoil for the agency. Last Sunday, FDA Commissioner Dr. Stephen Hahn overstated the effectiveness of convalescent plasma as a Covid-19 treatment during a White House press conference. He later amended his remarks about convalescent plasma’s risks and defended the FDA’s political independence, saying in a tweet: “This happens to be a political season but FDA will remain data driven.”
Meanwhile, President Trump promised a Covid-19 vaccine before the end of the year during his Republican National Convention address, and indicated he would like one authorized before the election, setting up a challenging situation for the FDA in which its reputation and the success of the overall recovery are on the line.
Gilead (ticker: GILD) shares climbed slightly in after-hours trading on Friday, up 0.6%, after falling 0.4% during the regular hours. It’s not clear how material the expanded authorization will be for Gilead’s sales: The U.S. government has already bought up the company’s entire projected production for July, August, and September. Analysts expect $2.3 billion in remdesivir sales this year, accounting for just under a tenth of Gilead’s projected overall sales, and another $2.3 billion next year, according to FactSet.
Still, evidence for remdesivir’s effectiveness remains limited. The FDA’s original emergency use authorization of the drug was based on a trial that showed that patients who received remdesivir recovered faster than patients who received a placebo. Gilead later published a retrospective analysis showing that the drug was associated with a 62% reduction in deaths, though the result has not been replicated in a randomized, controlled trial.
The FDA’s statement on Friday also cited another study, the results of which were published earlier in August in the Journal of the American Medical Association, that found that moderately ill patients in an unblinded trial who received a five-day course of remdesivir had better outcomes than patients who received the standard of care, but that patients who received a 10-day course of remdesivir had similar outcomes to patients who received the standard of care. “The difference was of uncertain clinical importance,” the trial’s authors concluded.
Dr. Hahn called the data supporting the expanded authorization encouraging. “The data show that this treatment has the potential to help even more hospitalized patients who are suffering from the effects of this devastating virus,” he said.
Gilead is currently testing an inhaled version of remdesivir for patients not currently authorized. Antivirals like remdesivir often work better when given earlier in the course of a sickness.
Shares of Gilead are up 0.4% this year. Gilead trades at 9.3 times earnings expected over the next 12 months, close to its five-year average of 9.4 times earnings. The stock had climbed on excitement over remdesivir, but fell early this month after the FDA rejected its application for a would-be blockbuster arthritis drug.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
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