FDA Authorizes Emergency Use of Regeneron’s COVID-19 Antibody Cocktail Taken by Trump

A sign for the Food And Drug Administration outside its headquarters in White Oak, Md., on July 20, 2020. Sarah Silbiger/Getty Images

The Food and Drug Administration (FDA) on Nov. 21 issued an emergency use authorization (EUA) for Regeneron’s combined antibody treatment that was given to President Donald Trump when he contracted the CCP virus (novel coronavirus) in October.

The treatment, formally known as REGN-COV2, contains two monoclonal antibodies named casirivimab and imdevimab, which have been shown to reduce COVID-19-related hospitalization or emergency room visits in high-risk patients when administered together. It’s meant for mild to moderate COVID-19 patients who are 12 years or older, or those who are at high risk of progressing to severe conditions related to the virus.

REGN-COV2 was one of the three pharmaceutical treatments given to Trump in October. Following his brief stay at Walter Reed National Military Medical Center, Trump announced that he was seeking an EUA for the antibody cocktail, which he described as the key to his rapid recovery from mild COVID-19 symptoms.

“I spent four days at [Walter Reed],” Trump said at the time. “I went in and I wasn’t feeling so hot. And within a very short period of time, they gave me Regeneron. It’s called Regeneron. And other things, too, but I think this was the key. They gave me Regeneron, and it was like unbelievable. I felt good immediately.”

President Donald Trump stands on the Truman Balcony after returning from Walter Reed National Military Medical Center at the White House on Oct. 5, 2020. Win McNamee/Getty Images

In a statement announcing the EUA, the FDA noted that lab-made monoclonal antibodies are able to mimic the immune system’s ability to fight off harmful pathogens such as viruses, and that casirivimab and imdevimab are specifically designed to block the CCP virus’s attachment and entry into human cells.

“The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” said Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research. “We will continue to facilitate the development, evaluation and availability of COVID-19 therapies.”

Leonard Schleifer, Regeneron’s CEO, said in a statement (pdf) that it would have 80,000 REGEN-COV2 treatment doses ready by the end of November, an additional 120,000 doses by the first week of January 2021, and another 100,000 doses by the end of January 2021.

“Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure REGEN-COV2 is distributed fairly and equitably to the patients most in need,” Schleifer said.

Last week, the FDA issued an EUA for the therapy baricitinib, in combination with remdesivir, for hospitalized COVID-19 patients requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. A clinic trial in October, which compared baricitinib plus remdesivir with remdesivir given as a standalone treatment, showed that the drug combination decreased the mortality rate by 35 percent.