The Food and Drug Administration has granted emergency authorization of a COVID-19 antibody treatment made by Eli Lilly that is similar to a therapy given to President Donald Trump shortly after he contracted the coronavirus.
The decision, announced Monday by the agency, is likely to be seen as a valuable tool to treat patients with COVID-19 at a time when the pandemic is raging across the United States, hospitals are overwhelmed and doctors have few options to treat the disease.
Eli Lilly said that its treatment, called bamlanivimab, should be administered as soon as possible after a positive coronavirus test, and within 10 days of developing symptoms. The authorization applies only to people newly infected with the virus, and the agency said it should not be used in hospitalized patients. It is authorized for people who are ages 12 and older and at risk for developing a severe form of COVID-19 or being hospitalized for the condition. The FDA said that included people who were over age 65 and obese — a key group that early studies have shown can benefit the most from the treatment.
“It’s a great day for science and medicine — sort of a feat of what’s possible,” said Dr. Daniel M. Skovronsky, chief scientific officer of Eli Lilly. The company and its collaborators, including the National Institutes of Health, he said, were able “to create a new drug, manufacture it, test it in clinical trials, and get it authorized for use in just seven months.”
In October, the company announced that it had reached a $375 million deal to sell 300,000 doses of the treatment to the U.S. government.
The emergency authorization for Eli Lilly raised immediate questions about who would get access to the treatment at a time when emergency authorizations for coronavirus vaccines might still be weeks or months away. The news came on the same day that Pfizer announced positive early results from its coronavirus vaccine trial. That vaccine might get emergency authorization sometime this year, but even then it would not be available to most Americans until well into 2021.
In a statement Monday, Alex Azar, the health secretary and a former executive at Eli Lilly, said the FDA’s emergency authorization for bamlanivimab was a “step forward” in “bridging us to the rollout of safe and effective vaccines.”
Eli Lilly has said that it expects to have enough doses to treat up to 1 million people by the end of the year, and that it will be able to significantly increase production thereafter. But that means that even in the best-case scenario, there won’t initially be enough to curb a virus that is now infecting more than 110,000 people a day in the United States.
“It’s kind of the best times for these therapies to enter, because they can have an impact,” said Dr. Walid F. Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh. “It’s also the worst time because we don’t have enough doses, and it’s going to add to the backlog of testing.”
Skovronsky said the company has been working “nonstop” since March to manufacture as many doses of the treatment as possible, without knowing if it would be successful. “It’s something I wish we had infinite supplies of medications of, for sure.”
Eli Lilly will begin shipping the treatment to national distributor AmerisourceBergen, which will allocate it with help from the federal government. AmerisourceBergen also helped distribute the antiviral drug remdesivir, the first drug that the FDA approved to treat COVID-19. The company said that decisions about distribution would be overseen by the federal government and would be based on the number of confirmed COVID-19 cases in each state or territory for the previous seven days. Each week, state health departments will then decide where those doses should go.
Antibody treatments enjoyed a burst of publicity in October when Trump received an infusion of a drug made by biotech company Regeneron and then enthusiastically promoted the drug. In a video released Oct. 7, the president claimed without evidence that it was a “cure.”
In early studies, Regeneron’s mixture of two powerful antibodies has shown promise at keeping the infection in check, reducing emergency room visits and hospitalizations in patients who get the treatment early in the course of their disease. Regeneron has also applied for emergency authorization with the FDA.
But it is impossible to know whether the Regeneron treatment helped Trump. He was given multiple drugs while at Walter Reed National Military Medical Center, and many people recover from the coronavirus on their own.
Last month, former Gov. Chris Christie of New Jersey, who spent time with Trump in the days leading up to his diagnosis, said he had received Eli Lilly’s experimental treatment shortly after he tested positive for the coronavirus.
For months, outside researchers have been closely watching the development of antibody treatments. And top White House officials have been agitating for faster progress. At one point over the summer, Dr. Deborah L. Birx, the White House’s coronavirus response coordinator, lashed out at drug officials on Operation Warp Speed, the administration’s vaccine and therapy development program, for what she saw as sluggishness in setting up clinical trials for antibody treatments, according to one senior administration official.
The president and two of his top advisers — Mark Meadows, the White House chief of staff, and Jared Kushner, Trump’s son-in-law — have called Dr. Stephen M. Hahn, the FDA commissioner, to press for speed in agency reviews, two other senior officials said.
Although neither Regeneron nor Eli Lilly has completed its antibody trials, evidence so far suggests that such treatments work best early in the course of the disease, before the virus has gained a foothold in the body.
The FDA’s emergency authorization covers only a single antibody treatment developed by Eli Lilly, but the company is also developing a combination of two antibodies that has shown that it could be more effective in reducing the viral load in patients. In an early analysis, the two-antibody combination reduced the hospitalization of newly infected patients by about 5%. Eli Lilly has said it plans to apply for emergency authorization for the combination treatment this month, but will only have about 50,000 doses of that therapy before the end of the year.
Early evidence shows that the antibody treatments do not work well once people are sick enough to be hospitalized. Eli Lilly stopped giving its treatment to hospitalized patients in a government-run trial, because the company said it did not seem to be helping them. And Regeneron paused enrolling the sickest hospitalized patients in one of its trials.
In issuing the emergency authorization, the FDA said that the treatment had not been shown to benefit hospitalized patients and that monoclonal antibodies like bamlanivimab might be associated with worse outcomes when given to hospitalized COVID-19 patients who need high-flow oxygen or mechanical ventilation.
This creates a problem for distributing the treatment, because it is only for people who are not hospitalized, yet those people must be infused intravenously by a health care provider. Getting it to the right people will require quick turnarounds in testing, as well as coordination among federal, state and hospital officials — many of the same challenges that have complicated the U.S. response to the pandemic.
Under the federal agreement with Eli Lilly, the treatment will be available at no cost to patients, though health care providers can charge to administer it.
The emergency use authorization, or EUA, was previously an obscure corner of regulatory law that mostly escaped broad public attention. But during the pandemic, it has become a centerpiece of the Trump administration’s health policy: Since February, the FDA has granted hundreds of emergency authorizations related to coronavirus, many for diagnostic tests and others for personal protective equipment, blood-purification devices, ventilators and therapies.
In making their decision, FDA scientists had to weigh the need for solid evidence that the treatment works with the urgent need for a useful drug as the pandemic accelerates again in the United States. Unlike a full FDA approval, which requires a rigorous vetting of clinical trial data showing a drug is safe and effective, an emergency authorization simply requires the potential benefits of a drug to outweigh its risks.
But the emergency authorization for Eli Lilly may have the unintended effect of complicating the role of clinical trials in proving the treatment’s effectiveness for different age groups. If the drug becomes more widely available, fewer people might want to sign up for clinical trials and risk the possibility that they will receive a placebo.