Topline
Treating the president with Regeneron’s experimental antibody therapy creates a “very tough situation” for the company as the therapy has not received approval for widespread use, the company’s CEO said.
President Donald Trump was treated with an experimental antibody therapy from Regeneron having been ... [+]
Key Facts
Trump was able to gain access to the experimental therapy — which is not currently available to most Americans — through a “compassionate use” request made by his doctors, which gives access to experimental treatments in life-threatening illnesses.
Regeneron’s CEO Leonard Schleifer told CNBC that it would have been impractical to enrol the president in a clinical trial, the only other means of accessing the treatment, and that the company has to balance the desire to help people with gaining concrete evidence of the therapy’s efficacy.
The New York Times reports that the company was preparing for an influx of compassionate use requests following the president’s treatment.
The company’s shares are up 6% in trading early Monday afternoon.
While analysts speculate that the president’s use of the drug could signal an impending approval by the FDA, Schleifer was quick to point out that White House does not play a role in determining FDA approval.
Crucial Quote
Regeneron’s CEO Leonard Schleifer told CNBC that the company approves compassionate use on a case-by-case basis and that President Donald Trump fit within that category. “Giving it to [Trump] or to others who might not be able or don’t qualify for clinical trials is the right use of compassionate use. That’s for small numbers of people, for these exceptions,” he said. “We want everybody to be potentially able to benefit. We understand we don’t make that decision. This is a decision the FDA has to make.”
Key Background
Trump was taken to Walter Reed Medical Center less than 24 hours after he was diagnosed with Covid-19 on Friday. In addition to Regeneron’s antibody therapy, the president also has received the experimental antiviral remdesivir, produced by Gilead Sciences and approved for use by the FDA under an emergency authorization, and the steroid dexamethasone, which is ordinarily reserved for severe cases.
What To Watch For
Keep an eye on the FDA. Clinical trials on Regeneron’s antibody therapy are underway and, if successful, could lead to the treatment’s wider approval and availability.
Further Reading
All The President’s Medicine (Forbes)
What You Need To Know About Trump’s Experimental Coronavirus Antibody Treatment (Forbes)
