- Regeneron CEO Leonard Schleifer was recently interviewed on CBS where he revealed that Donald Trump’s treatment is considered a “case of one.”
Over the weekend, Regeneron CEO Leonard Schleifer was interviewed and he said that President Donald Trump’s treatment with the company’s experimental antibody cocktail is considered “a case of one.” And he also stressed that the ongoing clinical trials still need to show its efficacy.
“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,” said Schleifer in an interview on CBS’ Face the Nation.
Schleifer also pointed out that there were some “very interesting aspects” in Trump’s case like his age. And Trump “did not have his own immune system in gear when he was sick and he got treated” with Regeneron’s experimental antibody cocktail.
While Trump’s case has become “the most analyzed case report ever,” it is “just low down on the evidence scale” that the company needs.
Trump was hospitalized at Walter Reed National Military Medical Center once he was diagnosed with COVID-19. After being treated with the antibody, Trump publicly touted it as a cure. And in an interview with Fox News, Trump said that he was immune from the virus.
At Walter Reed, Trump received 8 grams of Regeneron’s drug, REGN-COV2 — which is a combination of two monoclonal antibodies. Last month, Regeneron said its treatment was able to improve virus symptoms in non-hospitalized patients. However, it is unknown how the drug would work on patients in hospitals.
“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,” Schleifer added. “We’ve got some preliminary evidence that we’ve talked with the FDA, and we’re going for an emergency use authorization because we think it’s appropriate at this time.”
The antibody cocktail still has to receive emergency FDA approval. The government has a deal for 300,000 doses once it has approval. If the drug receives emergency approval, only 50,000 doses will be available.
“Regeneron can’t do this alone,” noted Schleifer. “We need the entire industry.”
And what is putting Regeneron in a tougher situation is that the requests for FDA “compassionate use” have significantly increased ever since Trump received treatment.