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The COVID-19 monoclonal antibody cocktail that President Donald Trump received as treatment in the hospital is available in limited supply, so the doses must be doled out to coronavirus patients who need it the most, the drugmaker's CEO said Sunday.
Trump called Regeneron's treatment a "cure" this week and vowed to distribute it to Americans for free. However, the company only has enough doses to treat 50,000 patients at the moment.
"We have to figure out ways to ration this," Leonard Schleifer, co-founder and CEO of Regeneron, said on the CBS News show "Face the Nation."
In July, the federal government signed a $450 million contract with Regeneron to create 300,000 doses. Those will be made available for free in upcoming months.
As of Oct. 11, The U.S. had 7.7 million reported cases and more than 214,000 deaths according to Johns Hopkins University.
Health officials will need to develop a distribution plan for the most vulnerable COVID-19 patients, Schleifer said, including older adults and those who face higher risks for severe disease. This would likely follow a distribution process similar to remdesivir, the antiviral drug made by Gilead Sciences to treat the coronavirus.
Regeneron filed for FDA emergency use authorization on Wednesday, the same day Trump posted a video online praising the treatment. Eli Lilly, another pharmaceutical company with a similar antibody treatment, applied for emergency authorization the same day.
Trump and White House staff urged the FDA to approve the treatment quickly, according to The New York Times. Stephen Hahn, the FDA commissioner, told Trump that the agency is reviewing the data.
Regeneron's treatment is being tested in late-stage clinical trials and is approved for "compassionate use," requiring case-by-case approval, as Trump received. Schleifer called Trump's case "interesting" but also noted that Trump's results were a "case of one."
"The real evidence has to come — about how good a drug is and what it will do on average — from these larger clinical trials, these randomized clinical trials, which are the gold standard," he said. "And those are ongoing."
The treatment works by helping the body create antibodies against the coronavirus. The immunity from an antibody cocktail likely lasts for months, Schleifer said, as compared with vaccine immunity that could last for a year or more.
"It can be used, we think, as a prophylactic," he added. "We're doing a trial to see whether or not, if you live in the household of somebody who's got it, whether it would stop you from getting it."
Schleifer said the data from that trial could be available in the "not too distant future." The company also plans to study the treatment in older adults for use in nursing homes and in immunocompromised adults who have weak immune systems.
"These are all really important questions," he said. "We're trying our best — while we're building this plane and flying it at the same time — to be ready to answer some of those questions as well."
CBS News, "Full transcript of 'Face the Nation' on October 11, 2020."
New York Times, "Regeneron's CEO says its promising Covid-19 treatment must be rationed."
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Cite this: Regeneron Must Ration COVID-19 Treatment, CEO Says - Medscape - Oct 12, 2020.