“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 informed CNN Business in an announcement.
It has not but been authorised by the Food and Drug Administration, nonetheless. The FDA can approve the administration of it by so-called compassionate use requests on a person foundation. Regeneron confirmed to CNN Business that one of many president’s medical doctors made such a request to Regeneron and the FDA to approve administering the drug to Trump.
Schleifer defended the choice to give Trump the cocktail final 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 assertion to CNN Business that it is “in discussions with the FDA about potential for an Emergency Use Authorization for REGN-COV2” following the discharge of constructive knowledge in regards to the drug final week.
Regeneron stated it is additionally within the strategy of finding out the impact of the cocktail on hospitalized sufferers, in addition to whether or not it could possibly forestall an infection in individuals who have been uncovered to Covid-19.
Dr. George Yancopoulos, Regeneron’s president and chief scientific officer, informed CNN’s Julia Chatterley in an interview Monday that the corporate is hoping it could possibly get extra doses of REGN-COV2 to sufferers inside the subsequent few months thanks to a partnership with Big Pharma big 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 stated. “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 model of this story misstated the compassionate use request course of. One of the president’s physicians made the request to Regeneron and the FDA.