President Donald Trump's use of Regeneron's experimental coronavirus treatment creates "a very tough situation" for the drugmaker since it hasn't been cleared for broader use, CEO Dr. Leonard Schleifer told CNBC on Monday.
The president, who announced Friday that he and first lady Melania Trump tested positive for the coronavirus, was given an 8 gram dose of Regeneron's monoclonal antibody treatment, his doctors said.
The company said it provided the drug to the president in response to a "compassionate use" request from Trump's doctors, which allows for expanded access to experimental drugs for "immediately life-threatening" illnesses, according to the Food and Drug Administration. It allows patients to access an investigational drug outside of clinical trials in lieu of adequate other treatments.
That means that while the president's doctors were confident enough of the drug's benefit to administer it to Trump, the treatment remains unavailable to most Americans.
"We have tried to take a principled approach until there is a broader authorization," Schleifer told CNBC's Meg Tirrell on "Squawk Box." "Asking somebody like the president to go into a clinical trial just wasn't practical."
Until the FDA takes a look at all the available data on the benefits and risk of the drug for Covid-19 patients, patients who want to receive the treatment should enroll in a clinical trial, Schleifer said. He added that patients in clinical trials are closely monitored so that researchers can understand how the drug affects the disease, but at least a third of patients will receive a placebo.
"Giving it to [Trump] or to others who might not be able or don't qualify for clinical trials is the right use of compassionate use. That's for small numbers of people, for these exceptions," he said. "We want everybody to be potentially able to benefit. We understand we don't make that decision. This is a decision the FDA has to make."
Schleifer added that he thinks the treatment meets "a lot of" the FDA's standards for an emergency authorization. But he said the company needs to continue to collect data in controlled clinical trials to better understand the treatment. But as trials continue, the virus continues to infect more than 40,000 people every day across the U.S.
"This is all very complicated because it's real lives at stake" he said. "If it's my loved one or your loved one, ... yes, we want to give this if we can help them. Of course, we want to get definitive evidence, so it's a tough act to balance."
Shares of the company were up more than 5% in early trading Monday.
Some analysts have speculated that the use of Regeneron's antibody cocktail to treat the president is a tacit endorsement of the drug and could signal a swift approval by the FDA. Schleifer, however, tried to assure the public in the CNBC interview that the FDA has its own standards for authorization and the White House does not play a role.
The class of drug has long been used to treat other infectious diseases, Schleifer said, making it a promising potential treatment for Covid-19. Other pharmaceutical firms, including Eli Lilly and GlaxoSmithKline, are also developing monoclonal antibody treatments.
Dr. Scott Gottlieb, Trump's former FDA commissioner, told CNBC last week that he "wouldn't infer anything from the fact they chose the Regeneron product over another product."
Earlier last week, Regeneron said the treatment improved symptoms and reduced viral loads in non-hospitalized patients who have mild to moderate Covid-19. That was based on results for the first 275 trial patients. At the time, the company indicated it plans to "rapidly" discuss the early results with regulatory agencies, including the FDA.
—CNBC's Christina Farr and Kevin Stankiewicz contributed to this report.
Disclosure: Scott Gottlieb is a CNBC contributor and is a member of the boards of Pfizer, genetic-testing start-up Tempus and biotech company Illumina. He also serves as co-chair of Norwegian Cruise Line Holdings′ and Royal Caribbean's "Healthy Sail Panel."
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