US could have 'hundreds of thousands' of doses of Regeneron's coronavirus antibody cocktail ready this fall: Firm scrambles for emergency FDA approval amid surging patient demand after Trump falsely called the drug a 'cure'
The US could have up to 300,000 doses of Regeneron's antibody treatment for coronavirus this fall, White House officials and the company said Thursday.
'We've applied the same methods to supporting therapeutics [as the government has to vaccine development] too,' Department of Health and Human Services (HHS) secretary Alex Azar said during a Thursday Goldman Sachs virtual event attended by CNN.
'That includes, for instance, support for both development and manufacturing of Regeneron's antibody cocktail, of which we could have tens or hundreds of thousands of doses this fall, pending FDA authorization.'
Coinciding with President Trump's passionate, though unproven, endorsement of the antibody cocktail as a 'cure' for coronavirus, Regeneron applied for emergency use authorization (EUA) from the FDA on Thursday.
In a statement, the company said it already has enough doses to treat 50,000 patients, and expects to ramp up manufacturing enough to make 300,000 doses of the experimental treatment 'in the next few months.'
Regeneron reiterated Trump's plans for the US government to make the drug free of cost to any American that needs it - but it remains entirely unclear how many figures its price tag might be.
Trump continued to promote the drug on Thursday, addressing seniors via nother Twitter video, and promising they would soon have access to the Regeneron's drug.
Its CEO, Leonard Schleifer, is a member of the Trump National golf club, and discussed the experimental antibody therapy Regeneron was developing with the president in May, The Guardian has revealed.
HHS Secretary Alex Azar said Thursday the US could have tens, if not hundreds, of thousands of doses of Regeneron's antibody cocktail this fall. The company sought emergency approval for its coronavirus therapy, which President Trump received and falsely hailed a 'cure,' and says it aims to make enough doses for 300,000 patients in the next few months (file)
Secretary Azar said that manufacturing for the drug would be scaled up under Operation Warp Speed (OWS), the initiative launched by the White House to speed the development and production of vaccines.
'OWS supported clinical trials continue for remdesivir in combination with other drugs. In addition to anticoagulants and other options,' Azar said at the Thursday virtual event.
'We're also supporting several randomized controlled clinical trials to produce more data on convalescent plasma, to which Americans have enjoyed broader access than anywhere on Earth.'
Already, clinical trials for Regeneron's injectable duo of lab-made antibodies, are seeing a surge interested patients hoping to enroll.
Dr Gary Kleiner, a pediatric immunologist at the University of Miami Miller School of Medicine and investigator in a trial designed to see if Regeneron's antibodies can prevent coronavirus infection, told Reuters he has been approached by patients seeking the drug since last week.
Dr Dirk Sostman, head of the research network at Houston Methodist Hospital, a trial site for Regeneron and Eli Lilly antibody programs, said more patients are asking to participate in an antibody trial.
He was cautious about broader use without more data.
'All we have seen are very brief press releases...so there is not much to go on,' he said.
'The politics of the situation would suggest to me that the story could be Trump gets COVID...then American technology fostered by the Trump Administration cures COVID,' Dr Sostman added.
'I would think there would be pressure on regulators.'
Top US infectious disease expert D. Anthony Fauci, speaking on Monday on CNN, said he was 'strongly suspicious' that Regeneron's drug has contributed to Trump's progress.
'Obviously you can't prove that until you do a number of studies to show that it actually works,' he said.
Doctors emphasized that the timeline for Trump's illness was not entirely clear. 'If he is responding at a pace where he is truly much better, it is going to be due to the antibodies,' Dr Edward Jones-Lopez, infectious disease specialist at the University of Southern California Keck School of Medicine in Los Angeles, told Reuters.
Giving the treatment to the president seems 'a tacit endorsement by the federal medical bureaucracy for Regeneron's medicine, and we expect an EUA for the treatment of COVID in a matter of days,' Leerink analyst Geoffrey Porges said in a research note.
'Patients most likely to benefit from this treatment have a similar profile to President Trump, in that they had undetectable antibodies at baseline and were early in the course of disease,' Regeneron spokeswoman Alexandra Bowie said in an emailed statement.
Regeneron has received $450 million from the U.S. government for up to 300,000 doses of the dual-antibody cocktail, and the company has said those supplies would be distributed free of charge.
President Donald Trump has admitted that Operation Warp Speed's former focus, a vaccine, will likely not be available until after the November 3 election and called the antibody cocktail drug he received as treatment for the coronavirus a 'cure'.
In a video shared on Twitter, Trump addressed the American people's concerns for a vaccine to combat the virus that has killed more than 210,000 people and infected more than 7 million others in the US alone. The president has repeatedly expressed his wish for a vaccine to be available prior to the election.
'We're going to have a great vaccine very, very shortly. I think we should have it before the election, but frankly the politics gets involved and that's OK,' Trump said in the video that was recorded outside the White House.
A maskless Trump continued: 'They want to play their games. It's going to be right after the election.
'The FDA has acted as quickly as they've ever acted in history,' Trump said. 'No president has ever pushed them like I've pushed them either, to be honest with you.'
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President Donald Trump has admitted that a vaccine will likely not be available until after the November 3 election and falsely called the antibody cocktail drug he received as treatment for the coronavirus a 'cure'
In the same video, Trump falsely called the experimental Regeneron drug a 'cure'. Trump received the drug while being treated for the virus at Walter Reed over the weekend.
Trump said that hundreds of thousands of doses are 'just about ready to go, I have emergency use authorization all set'.
Regeneron, which makes the experimental drug given to President Trump, had not announced the submission of its application for emergency use authorization with the Food and Drug Administration (FDA) at the time of Trump's Twitter video.
Later Wednesday night, the company confirmed it had submitted its application in a press release dated the same day.
Eli Lilly, which makes a similar competing antibody drug, announced it had asked the FDA for emergency approval of its own combination antibody treatment on Wednesday.
'I think it was a blessing from God that I caught this, it was a blessing in disguise I caught it, because I heard about this drug and it was my suggestion that we try it and it was incredible the way it worked....and I want you to get what I got,' Trump said.
The president offered no details on how he planned to make Regeneron's antibody cocktail free and there is no data to suggest that the drug is a cure.
Presidents also do not hold the power to give regulatory approval to drugs.
Earlier this week, the White House approved FDA rules that make it nearly impossible for the agency to give emergency approval to a shot ahead of Election Day.
Trump said an emergency use authorization for Regeneron's antibody drug (pictured left, in development) is 'set.' The company has not submitted for FDA approval. Eli Lilly makes a similar therapeutic combination (pictured right, in development), and applied for emergency approval on Wednesday. Trump was not treated with Lilly's drug
Conflating the Regeneron treatment that he received and its competitor's antibody treatment, Trump said: 'We have these drugs from Eli Lilly and others that are so good that they are, in my opinion - remember, they're going to say that they are therapeutic, some people don't know how to define therapeutic - but I view it different, for me, it's a cure.'
Regeron applied for emergency use authorization (EUA) on Tuesday after publishing its first data from trials of its antibody cocktail, REGN-COV2, last week.
REGN-COV2 is a 'cocktail' of two lab-made versions of immune proteins the body naturally develops to fight off COVID-19 once exposed.
Coronavirus patients who were not sick enough to be hospitalized and treated with the drug saw their viral loads decline twice as far as did patients who got placebo.
People who got the antibody treatment recovered and had fewer or no symptoms in about half the time it took people who received the sham treatment to reach that level of improvement.
None of the patients in the study - regardless of whether they got the antibody cocktail or a placebo - died, so there is no way to know if it reduces the risk that someone will die of COVID-19.
Regeneron has not revealed the results of tests for its drug in hospitalized patients.
Eli Lilly asked the FDA to allow emergency use of its experimental antibody therapy for coronavirus, the firm announced Wednesday.
Its application is based on early results from a study that suggested the drug reduced symptoms, the amount of virus, hospitalizations and ER visits for patients with mild or moderate COVID-19.
Trump was not treated with Lilly's drug.
In addition to Regeneron's antibody cocktail, the president received Gilead's antiviral remdesivir and the steroid dexamethasone.
Remdesivir and dexamethasone have both been shown to reduce mortality from COVID-19 in clinical trials.
The FDA has issued an EUA for remdesivir to treat COVID-19 patients. Dexamethasone has not been given that distinction, though it is approved for other uses. The steroid is also only indicated for treating severely ill patients, and may actually harm people with milder cases.
Moreover, 'the president has just received probably the best medical care that anyone could see and that is accessible to almost nobody else in the US,' Dr Craig Bryan, a psychiatrist at Ohio State University told DailyMail.com in a recent interview.
President Trump's free-wheeling promises came shortly after his executive order for the Departments of Defense and of Veteran Affairs to launch an investigation into the links between the pandemic and suicides.
'If I get sick, I'm going to not get treatment or go into debt getting treatment that could save my life and potentially the lives of my loved ones,' said Dr Bryan.
'All of these things I think would be astronomically more more impactful for suicide prevention,' than the plan to reduce the potential mental health fallout of the pandemic that the president has demanded be drawn up in the next 45 days.
Now, Trump claims he will make his bespoke treatment course available to anyone in the US, for free.
'If you're in the hospital and you're feeling really bad, I think we're going to work it so you get them and you get them free, especially if you're a senior, we're going to get you in there quick,' he said.
'I want everybody to get the same treatment as your president got, because I feel great, I feel perfect.'
A five-day treatment course of remdesivir is estimated to cost $3,120.
About 20 per cent of people who catch coronavirus seek some form of treatment, according to the World Health Organization (WHO).
On Tuesday, 43,562 new US cases of COVID-19 were reported in the US, according to figures from Johns Hopkins University.
Treating 20 percent of them with remdesivir would cost the US government about $27.2million - and that rough estimate is for just one day.
Dexamethasone costs just $6, but is only used in severely ill patients.
Neither Eli Lilly nor Regeneron have given possible price points for their experimental drugs, but while experts have anticipated the development of antibody drugs as potentially the most effective, they've warned that they could be prohibitively expensive.
And this is all assuming the drugs are approved.
Trump alternated between praising and criticizing the FDA, the agency that will have to issue the approvals he is now promising.
'The FDA has acted as quickly as they've ever acted in history and there's never been a time [like this] and no president has ever pushed them like I've pushed them, to be honest with you,' he said.
His insinuations of a 'cure' have also been blamed for pushing the FDA to give emergency approval to the malaria drug hydroxychloroquine, which Trump also took.
That approval had to be retracted, after data showed the drug did not offer any preventive or therapeutic benefit to patients, and may have raised mortality risks in some by triggering heart problems.
Trump's rush to approve vaccines has also fueled distrust in vaccines developed under Operation Warp Speed, with half of Americans saying they are unsure if they will get the first shot developed to prevent COVID-19.
FDA regulators got stricter approval guidelines for coronavirus vaccines approved by the White House Tuesday, in an effort to rebuild that trust, and effectively putting an end to Trump's hopes to get a vaccine approved by the November 3 election.
'They call them therapeutic,' Trump said of treatments like Regeneron's antibody cocktail, 'but I call them a cure.
'So we have to get them done and get them to the hospital where people are feeling badly, that's much more important than the vaccine but on vaccines, we have many companies that are in the final stages for vaccines - Johnson & Johnson, Moderna, Pfizer -all great companies, and many of them are going to have a great vaccine very shortly.
'I think we should have it before the election, but frankly the politics gets involved that's okay, they want to play their games, it's going to be right after the election, but we did it, nobody else, nobody else would have ever been able to.'
The US has approved no vaccines to prevent coronavirus. No shot-makers have compiled enough data to submit for emergency use authorization from the FDA.
Only two treatments have been given EUAs: remdesivir, which offers moderate reduction in death risks, and convalescent plasma, which may offer no benefit.
More than 7.5 million Americans have tested positive for COVID-19. That's assumed to be an underestimate.
Yesterday, 705 Americans lost their lives to the virus. To-date, at least 211,513 people have died of COVID-19, and the toll is expected to surpass 363,00 before Inauguration Day.
