In a video released Wednesday, President Donald Trump talked up the benefits of an experimental drug that he credited for “curing” him of COVID-19. He pledged to make the therapy freely available to all Americans.
Trump received REGN-COV2, made by Regeneron, a New York biotech company, after testing positive last week for the disease. The drug, a pair of monoclonal antibodies, is intended to mimic the natural process of the immune system, providing it with molecules the body normally manufactures to fight off specific diseases.
It is currently being tested in people at various stages of the disease, including patients who have been diagnosed with COVID-19 and are symptomatic but not hospitalized, as was Trump.
It also is being considered as a prophylactic treatment to prevent infection in people who have been exposed to SARS-CoV-2, the virus that causes COVID-19.
The drug remains under development and is not yet approved for use in the United States or anywhere else. It appears to be safe but has not yet been proven effective in clinical trials at treating or preventing COVID-19.
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Trump was able to get it under a “compassionate use” exemption, which the company said it has granted to fewer than 10 people so far, after requests from their doctors and approval by the U.S. Food and Drug Administration, a process that typically takes days to weeks.
Regeneron said compassionate use is “only for rare and exceptional circumstances as we don’t want to raise false hopes among the many patients out there,” according company spokeswoman Alexandra Bowie.
Otherwise, about 2,000 people have taken REGN-COV2 as part of clinical trials designed to ensure that it is safe and effective. The drug is not yet available outside of of trials and the supply is currently very limited.
“So we’re going to get you the drug. It’s going to be free. We’re going to get it into the hospitals as soon as you can, as soon as we can,” Trump said in the video filmed outside the White House on Wednesday evening.
Regeneron has not yet applied for approval of the drug with the FDA so it has not yet begun the process necessary to make it available to a broad patient population. Eli Lily and Co., which is making a similar product, applied to the FDA Wednesday for an emergency use authorization.
Eli Lilly chairman and CEO David Ricks said in a telephone news conference Wednesday studies so far in about 550 volunteers show his company’s monoclonal antibodies to be safe and to reduce patients’ viral load, symptoms and hospital visits.
A larger study is needed to confirm these findings.
“Patients who fail to clear their virus are the ones who are doomed to have worse outcomes from the disease,” said Dr. Daniel Skovronsky, Lilly’s chief scientific officer. “The goal is to give the immune system time to knock it out.”
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In one study, nearly 6% of patients on a placebo ended up hospitalized, compared to only 1% of those who took Lilly’s combination of antibodies. Skovronsky said studies show that the 700 mg dose of antibody LY-CoV555 is not any less effective than higher doses, and the company plans to test even lower doses going forward.
Lower doses would allow the same amount of antibody to help more people. Lilly’s antibodies also are only available so far via clinical trials, though the company has begun large-scale manufacturing. Ricks said he expects to have about 50,000 doses of LY-CoV555 by the end of this year and a million next year, and pledged to make the drug affordable both in the U.S. and other parts of the world.
“We hope patients pay nothing or almost nothing out of pocket,” he said.
Typically, monoclonal antibodies are extremely expensive. Cancer-related monoclonal antibodies often cost nearly $100,000 a year, according to one 2018 study. For COVID-19, monoclonal antibodies are expected to be orders of magnitude cheaper, likely a few thousand dollars for a single-dose regimen.
Supply likely will remain tight even after approval because such biologic drugs are complex and time-consuming to manufacture.
The federal government paid $450 million to Regeneron in July to launch a demonstration project to manufacture the drug. It will own doses that result from the project.
The company estimated at the time between 70,000 and 300,000 treatment doses could be available from the project this fall.
REGN-COV2 includes two antibodies. One comes from a person who recovered from COVID-19, the other is from a mouse engineered to have a human immune system. Both target a protein on the surface of the coronavirus that causes COVID-19.
Trump said he wanted the experimental treatment for everyone.
“I want everybody to be given the same treatment as your president, because I feel great. I feel like perfect. So I think this was a blessing from God that I caught it. This was a blessing in disguise.”
Contact Karen Weintraub at kweintraub@usatoday.com and Elizabeth Weise at eweise@usatoday.com
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
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