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Regeneron and Eli Lilly, two pharmaceutical companies that have created antibody therapy drugs for COVID-19, applied for FDA emergency use authorizations on Wednesday ― the same day President Donald Trump posted a video calling the antibody drugs a "cure."
Trump received Regeneron's monoclonal antibody drug combination after his coronavirus diagnosis last week. He called the therapeutic drug a cure, although there's not enough scientific data to fully determine whether the therapy is effective in COVID-19 patients. There is no known cure for the coronavirus.
"It was, like, unbelievable," he said in a video posted on Twitter on Wednesday. "I felt good immediately."
Trump vowed to make the drugs available for free to anyone who needs them, particularly older adults who may face severe COVID-19. He said the drugs were even more important to him than a COVID-19 vaccine and he'd like to ship doses to hospitals across the country as "soon as we can."
"I want everybody to be given the same treatment as your president," he said. "I feel great. I feel perfect."
Regeneron's experimental monoclonal antibody therapy is still being tested in large clinical trials but has been available to a small group of patients under the FDA's compassionate use guideline, which requires individual approval, as was given for Trump. At this time, the company has enough manufactured doses for about 50,000 patients, the company posted on its website on Wednesday.
"If an EUA [emergency use authorization] is granted, the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution," according to the statement. "We expect to have doses available for 300,000 patients in total within the next few months."
The "cocktail" antibody, as it has been called, combines two lab-created monoclonal antibodies to block the effects of COVID-19 on the body. The antibodies target two parts of the coronavirus, including the spike protein that allows the virus to dig into healthy cells and replicate quickly. The therapy reduces viral load and the time it takes for symptoms to clear up, the company announced a few days before Trump was given the treatment.
Early study data shows that the Regeneron therapy is safe and has few side effects, according to CNN. Human clinical trials began in June, and late-stage trials started in July. Some scientists are awaiting more data and a peer review to decide how well the drug works.
"I would withhold judgment on this until we see the data," Richard Besser, former acting director of the CDC and now head of the Robert Wood Johnson Foundation, told CNN.
"You know these early results that keep coming out from companies in press releases strike me as being ... much more about the stock price than they are about science," he said.
At least 70 other COVID-19 antibody treatments are being tested. Among those, Eli Lilly also submitted a request to the FDA on Wednesday for emergency use authorization of its single monoclonal antibody therapy. The company expects to submit an application for its combination therapy in November.
The company could have 100,000 doses available this month and 1 million doses ready by late December, according to CNN.
"Our expectation is that there shouldn't be a cost to patients," Daniel Skovronsky, MD, the chief scientific officer for Eli Lilly, told CNN on Wednesday.
Alongside the requests for FDA emergency use authorizations, both companies will continue to study the antibody therapies in large clinical trials, which will provide better data on safety and how well the treatments work.
"Randomized clinical trials to answer these questions are now a priority," Martin Landray, PhD, an epidemiologist at the University of Oxford, told the Science Media Centre in the U.K.
There is a "way to go" before the data shows whether these antibody drugs can effectively reduce severe forms of COVID-19, he said. This requires important data on hospital admissions, the length of hospital stays, the need for mechanical ventilation, and survival rates among coronavirus patients.
"It is encouraging to see that both Eli Lilly and Regeneron have active plans for much larger trials in a range of different settings, including residential care homes, outpatients, and hospital inpatients," Landray said.
Mashable: "Trump falsely claims there's 'a cure' for COVID-19 in rambling Facebook, Twitter posts."
Regeneron: "Statement on REGN-COV2 Emergency Use Authorization Request," "Regeneron's REGN-COV2 Antibody Cocktail Reduced Viral Levels and Improved Symptoms in Non-Hospitalized COVID-19 Patients."
CNN: "Regeneron asks FDA for emergency authorization of its Covid-19 antibody therapy given to Trump last week," "Eli Lilly seeks EUA from FDA for Covid-19 antibody treatment."
Eli Lilly: "Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs."
Science Media Centre: "Expert reaction to press release from Lilly on their neutralizing antibodies being trialed as treatment for COVID-19."
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Cite this: Trump Touts Unproven Therapy as COVID 'Cure' - Medscape - Oct 08, 2020.