The Food and Drug Administration will authorize Gilead Sciences Inc.’s remdesivir, a decade-old experimental therapy first tested on Ebola disease patients, as a COVID-19 treatment.
Gilead CEO Daniel O’Day told investors during an earnings call that talks with the FDA about an emergency use authorization (EUA) or a formal approval have intensified over the last 48 hours. “There’s a big sense of urgency,” he said, according to a FactSet transcript of the call. “We think the FDA will move quite quickly.” Shares of Gilead GILD, -4.84% were down 6.9% on Friday following at least three downgrades of the stock on concerns about remdesivir’s moneymaking potential. (“We don’t know what a sustainable revenue stream from remdesivir will look like,” SunTrust Robinson Humphrey analysts wrote in a note.) Year-to-date, the company’s stock has gained 20.4%, hitting a low of $62.23 on Jan. 21 before soaring to a $85.97 high for the year on March 19. The drug has been widely considered a front-runner in the rush to find viable treatments for a disease that has sickened more than three million people worldwide and killed at least 220,000, according to data aggregated by Johns Hopkins University. It would be the first new drug to get an EUA, a type of authorization that the FDA is using during the pandemic. The regulator in March authorized chloroquine and hydroxychloroquine to be repurposed for some COVID-19 patients though both drugs have previously been approved to treat other diseases, like malaria. Investors and clinicians have been paying close attention to the snippets of study data about the antiviral drugs, sending the company’s shares up or down depending on the day. Though experts have had mixed responses to the clinical findings so far, it’s clear that demand is high. There are no proven treatments for infections caused by the coronavirus, making it difficult for the nation’s health-care workers to care for the patients who end up in their emergency rooms and intensive care unit beds. There’s also the economic angle. The market largely swings up in response to remdesivir data, driven by the investor stance that a proven treatment, even more so than vaccine, would support the prospect of an economic rebound for the U.S., which is in its worst recession since the Great Depression. Gilead began developing remdesivir in 2009. It was later tested as a treatment for Ebola, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS), among other diseases. The company said it began providing doses of remdesivir to the China Centers for Disease Control and Prevention & Prevention in January when the coronavirus outbreak there began to worsen. By February, the investigational therapy had been moved into a number of clinical trials in the U.S. and abroad, including one conducted by the National Institute of Allergy and Infectious Diseases (NIAID). Government officials including President Trump and Dr. Anthony Fauci, the NIAID director, have talked up the results, with Fauci saying remdesivir would become the standard of care in the treatment of COVID-19 patients, other medical experts have been more measured in their responses to the clinical-trial data. “Under the emergency-use authorization, one could charge for the product,” CEO O’Day told investors on the earnings call. “We made a decision, as you know, to donate 1.5 million vials, which is the entirety of our supply through the early summer.” The vials encompass 140,000 10-day treatment courses. O’Day later said during the call that donating the investigational therapy “is the right thing to do at this time.”