Regeneron Pharmaceuticals has submitted a request for emergency authorization to the FDA for its experimental antibody treatment for coronavirus.


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President Donald Trump has called the antibody cocktail he received to fend off the coronavirus “a cure,” but the chief executive of Regeneron Pharmaceuticals Inc. said Sunday that Trump’s case is merely “a case of one,” and the treatment still needs more testing before its efficacy is known.

In an interview with CBS News’ “Face the Nation,” Regeneron
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CEO Leonard Schleifer — whose company made the experimental drug cocktail that apparently helped Trump — warned against jumping to conclusions.

“So the president’s case is a case of one, and that’s what we call a case report, and it is evidence of what’s happening, but it’s kind of the weakest evidence that you can get,” he said, according to a CBS News transcript.

Schleifer said that while Trump’s case had “some very interesting aspects,” such as his age and risk factors, his results are “just low down on the evidence scale that we really need.”

“The real evidence has to come — about how good a drug is and what it will do on average — has to come from these large clinical trials, these randomized clinical trials, which are the gold standard. And those are ongoing,” he said.

Trump’s doctors said Saturday the president was no longer at risk of spreading the virus, and Trump told Fox News on Sunday that he’s now immune to COVID-19.

Schleifer was cautious in that assessment as well. While saying the Regeneron drug “does” create immunity, it’s not known how long it lasts. “Could be months, could be years,” he said. “If you get it in our vial, if you will, that’s probably going to last you for months.” 

Schleifer also addressed Trump’s call for the Regeneron drug to be distributed for free to all who need it. The U.S. government has bought 300,000 doses for $450 million, which will be distributed for free, and Schleifer said there are already 50,000 doses ready to go.

Still, with the U.S. averaging nearly 50,000 new cases a day last week, “It’s not enough,” Schleifer said, adding that if the drug is found to be effective, other drug makers will be needed to pitch in on production. “Regeneron can’t do this alone. We need the entire industry,” he said.

Until then, he said the government and local health authorities should decide who gets the drug. “The vulnerable people, elderly people, people who are at high risk, household contacts perhaps. We have to figure out ways to ration this,” he said.

Regeneron shares are up 60% year to date, compared to the S&P 500’s
SPX,
+0.87%

7.6% gain this year.

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