Trump’s experimental treatment from Regeneron puts the company in a ‘very tough situation’ as others request early access, CEO says

• President Donald Trump’s use of Regeneron Pharmaceutical’s experimental monoclonal antibody treatment puts the company in “a very tough situation,” CEO Leonard Schleifer says.
• The US President was given an 8 gram injection of Regeneron’s drug over the weekend under the FDA’s “compassionate use” option, as Schleifer said it “just wasn’t practical” to ask a government official to enter a clinical trial.
• But as infections in the US rise and more than 210,000 Americans have lost their lives from COVID-19, many of those infected and seeking early access like Trump won’t qualify for compassionate use.
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President Donald Trump recently took Regeneron Pharmaceutical’s experimental monoclonal antibody treatment, and that has put the company in a difficult situation as it’s starting to receive more requests for early access via the FDA’s “compassionate use” approval process.

Regeneron’s CEO, Dr. Leonard Schleifer, talked generally about the recent development in an interview on Monday while appearing on CNBC’s “Squawk Box” with Meg Tirrell. 

“It’s a very tough situation. We have tried to take a principled approach until there is a broader authorization,” Schleifer said during the interview with CNBC. “Basically, if you can get into clinical trials, we’ve tried to encourage people to go into well-controlled, well-monitored, carefully collected data in a clinical trial setting.”

Schleifer added that it “just wasn’t practical” to ask someone such as Trump to enter a clinical trial. Going into a clinical trial has its downsides, Schleifer said, also noting that “you have a 1 in 3 chance of getting placebo.”

Trump was given an 8 gram injection of Regeneron’s drug over the weekend, which is called REGN-COV2 and is a combination of two monoclonal antibodies. The New York-based biotech firm began clinical trials for its experimental treatment on June 11.

Regeneron in the last week said that its drug helped cut down on viral loads and improved symptoms in non-hospitalized COVID-19 patients, with signs it could reduce the chance of someone infected requiring hospitalization.

Schleifer additionally reiterated that the FDA has yet to approve of Regeneron’s drug, and that it was reasonable for someone like Trump to have received it early.

“We want everyone to be potentially able to benefit, we understand we don’t make that decision — this is a decision that the FDA has to make,” he said. “If you’re an essential member of government and you have to conduct the people’s business and the continuity of government and you can’t get to a clinical trial, we’ll take that into account.”

More than 210,000 Americans have lost their lives from COVID-19, according to data from Johns Hopkins University, and new infections continue to spike in some areas of the US.

Schleifer emphasized that the decision to take his company’s experimental monoclonal antibody treatment isn’t something that should be taken lightly, but that he understands people reaching out to inquire about compassionate use access.

“This is all very complicated because it’s real lives at stake,” Schleifer said. “If it’s someone you really care about — yes, we want to give this if we can and we help them, but of course we want to get definitive evidence. So it’s a tough act to balance.”

On Friday, Trump tweeted that he and first lady Melania Trump had tested positive for the coronavirus. They went into isolation, with early news from the White House indicating Trump “was fatigued,” while The New York Times reported that the President “had mild coldlike symptoms.”

Trump was then transported from the White House to the Walter Reed National Military Medical Center in Bethesda, Maryland, where he stayed over the weekend before leaving Monday night.

White House physician Dr. Sean Conley, who’s received backlash for dodging specific questions and not providing enough detailed information in regards to the president’s health, announced on Tuesday that Trump hadn’t reported any symptoms.

“He had a restful first night at home, and today he reports no symptoms,” Conley said. “Overall he continues to do extremely well, I will provide updates as we know more.”