“Len and President Trump are acquaintances from both living in the Westchester area for many years but didn’t have any regular contact until this year, when they’ve discussed matters around Covid on occasion,” Regeneron told CNN Business in a statement.
It has not yet been approved by the Food and Drug Administration, however. The FDA can approve the administration of it through so-called compassionate use requests on an individual basis. Regeneron confirmed to CNN Business that one of the president’s doctors made such a request to Regeneron and the FDA to approve administering the drug to Trump.
Schleifer defended the decision to give Trump the cocktail last week, telling CNN’s Wolf Blitzer that Trump “is in a higher-risk group for a variety of reasons” and that “we hope that we will give his immune system enough of a boost so that he can win this and make a complete recovery.”
“We’ve got a lot of data, but we’re still in the experimental phase. But when you’re in the midst of a pandemic and you have people at risk, we think it makes sense to try these,” Schleifer added.
Regeneron added in its statement to CNN Business that it is “in discussions with the FDA about potential for an Emergency Use Authorization for REGN-COV2” following the release of positive data about the drug last week.
Regeneron said it is also in the process of studying the effect of the cocktail on hospitalized patients, as well as whether it can prevent infection in people who have been exposed to Covid-19.
Dr. George Yancopoulos, Regeneron’s president and chief scientific officer, told CNN’s Julia Chatterley in an interview Monday that the company is hoping it can get more doses of REGN-COV2 to patients within the next few months thanks to a partnership with Big Pharma giant Roche.
“We are on track to deliver 300,000 doses by the end of the year and…produce 300,000 doses a month while the demand may even still exceed that,” Yancopoulos said. “If the drug is really working and having the effects that we all hope it would, it could be doing a lot of good for a lot of people.”
Correction: An earlier version of this story misstated the compassionate use request process. One of the president’s physicians made the request to Regeneron and the FDA.