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President Donald Trump has received a dose of an experimental antibody treatment being developed by drugmaker Regeneron, in addition to several other drugs, including zinc, vitamin D and the generic version of the heartburn treatment Pepcid, according to a letter from his doctor released by the White House.
Regeneron has a large manufacturing facility in Limerick, where it employs more than 1,000 people.
Mr Trump was given REGN-COV2 before he travelled in a helicopter to Walter Reed National Military Medical Centre on Friday. This product is not currently being manufactured in Limerick.
However, Regeneron is planning to add more than 400 new jobs at its Limerick facility to support its medicine production.
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This is because some medicine production is be moved from its New York plant to allow it focus on REGN-COV2.
In the letter, Mr Trump's doctor, Dr Sean Conley, said "he completed the infusion without incident".
There are no approved treatments for Covid-19, but the Regeneron treatment is considered one of the more promising candidates, along with another antibody treatment developed by Eli Lilly.
Both are being tested in patients in the US. Initial results have suggested they can reduce the level of the virus in the body and possibly shorten hospital stays, when given early in the course of infection.
Although Regeneron’s product has not been authorised for emergency use by the US Food and Drug Administration, companies can grant access to their experimental treatments through compassionate use.
Permission
On Friday, Regeneron's chief executive, Dr Leonard Schleifer, said Mr Trump's medical staff contacted the company for permission to use the drug and this was cleared with the FDA.
“All we can say is that they asked to be able to use it, and we were happy to oblige,” he said.
He added that so-called compassionate-use cases - when patients are granted access to an experimental treatment outside a clinical trial - are decided on a case-by-case basis, and the president was not the first patient granted permission to use the treatment this way.
When it's the president of the United States that "gets our attention." Mr Schleifer has known Mr Trump casually for years, having been a member of his golf club in Westchester County.
George Yancopoulos, Regeneron's president and chief scientific officer, said the company was preparing for an influx of requests.
“This is certainly putting us in a difficult situation,” Mr Yancopoulos said.
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The company is also planning for how to allocate the product if it is authorised for emergency use or approved.
Regeneron has an arrangement with the US Department of Defense to distribute the first 300,000 doses once it is available.
“We didn’t want to decide who gets a limited number of doses,” he said.
During the pandemic, Mr Trump has promoted a range of unproven or scientifically questionable treatments for the virus and himself took the malaria drug hydroxychloroquine in the hopes that it could prevent infection.
Hydroxychloroquine
The FDA authorized hydroxychloroquine for emergency use this spring, then revoked its approval after concluding that the drug’s potential benefits did not outweigh the risks.
Mr Trump has also enthusiastically endorsed the use of convalescent plasma and pushed for the FDA to authorize the treatment for emergency use even though there is still not good evidence that it works.
He suggested that injecting a disinfectant like bleach could help combat the virus, although later said he was joking.
Other treatments - an inexpensive steroid, dexamethasone, and remdesivir, an antiviral drug developed by Gilead - have been shown in clinical trials to help patients with Covid-19 who are sick enough to be hospitalized.
Neither drug has gone through the rigorous FDA approval process to determine that it is safe and effective, although dexamethasone is widely available for other uses, and remdesivir has received emergency authorization.
Mr Conley said in his letter that in addition to the Regeneron treatment, Mr Trump was also taking zinc, vitamin D, melatonin, a daily aspirin and famotidine, the generic name for the heartburn drug Pepcid.
Some of these products, which are widely available, have been studied as treatments for Covid-19, although none have been definitively proven to work.
Regeneron and Eli Lilly are the furthest along of several companies and teams of researchers in developing what are known as monoclonal antibodies to fight Covid-19.
Researchers identify powerful antibodies that fight infection, then manufacture them in large quantities. They are then given to sick patients or to people who have been exposed to the virus, in the hopes that they will help boost the body’s immune response.
Antibody treatments have shown promise against other viruses, including Ebola. - New York Times