May 1, 2020
By Naomi Lopez
The Goldwater Institute’s dedicated coverage of the COVID-19 crisis has been closely monitoring the accelerated development process for both vaccines and treatments. Two weeks ago, we discussed the promising, initial results of an observational study of remdesivir that was published in the New England Journal of Medicine.
Now, today, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization for remdesivir. In times of declared public health emergencies, such as the current crisis, the FDA Commissioner may authorize unapproved treatments. This treatment is an important tool in the arsenal of COVID-19 responses, and the FDA should be lauded for taking this important step.
Remdesivir is a “broad spectrum” drug that showed promise in the lab and in animal studies for Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS), both coronaviruses. That is why it was thought of as a potential treatment for COVID-19. Today, in an ongoing study of more than 1,000 patients being conducted by the National Institute of Allergy and Infectious Diseases (which is led by Dr. Anthony Fauci), it is being reported that remdesivir improves sick patients’ outcomes, meeting its primary “endpoint” or treatment goal.
Initial data found that remdesivir reduced sick patients’ median recovery time from 15 to 11 days. The data also suggested a survival benefit, with a mortality rate of 8 percent for the group receiving the treatment versus 11.6 percent for the patients that received a placebo. Speaking to reporters on Wednesday, Fauci said, “This will be the standard of care.”
Unlike the observational study that we previously discussed, the government study is the most rigorous, to date, meeting the high standards of a randomized, controlled evaluation. Later-stage clinical trials have already been ongoing in China, the U.S., and several other countries.
Beginning in late January, Gilead, the company that makes remdesivir, began offering the treatment on an emergency basis for hospitalized patients who didn’t qualify for a clinical trial. More than 1,800 patients were treated outside of clinical trials in multiple countries, but remdesivir is not yet a fully approved treatment for COVID-19 in any country. In order to obtain full FDA approval, Gilead will be required to compete the FDA clinical trial process or, at a minimum, complete an expedited or “fast-track” approval process.
There is no reason to believe that remdesivir is a silver bullet treatment or that, now that a treatment has been authorized, we are in the clear. However, this is an important step forward and will keep many patients from deeper severity and longer durations of their illnesses. This treatment, of course, also has important implications for the individual patients, but it also impacts the medical resources, including hospital beds, that are required to care for the more severely ill patients.
The FDA’s emergency authorization is an important reminder of what the Goldwater Institute’s work of getting the right treatment, to the right patient, at the right time means. Now that we are in the midst of rapid medical innovation that holds the promise of treatment and immunization on a shorter timeline, in the fight against this pandemic, there is a growing realization that today’s FDA, which has responded and adapted quickly in some areas, has historically been slow to cut the red tape and accelerate the innovations for all patients that we now see taking place.
Naomi Lopez is the Director of Healthcare Policy at the Goldwater Institute.