FDA Grants Emergency Use Approval for Regeneron COVID-19 Treatment, But There's a Catch

The U.S. Food and Drug Administration (FDA) granted on Saturday an emergency use authorization for Regeneron's COVID-19 antibody treatment.

Regeneron's experimental therapy was also given to President Donald Trump when he contracted the coronavirus in October, noted a Reuters report.

Regeneron submitted its application to the FDA that month after its preclinical studies showed promising results.

But the FDA said the treatment can only be used for mild cases of COVID-19. It can't be used for hospitalized COVID-19 patients.

It can also be given to pediatric patients with positive coronavirus test results who are at high risk of progressing to severe illness, those who are 65 years old or older and or those who have certain chronic medical conditions.

What Did Regeneron's Study Prove During Trials?

According to CNBC, the therapy called REGN-COV12 managed to reduce the amount of virus and lung damage in non-human primates.

The company also claimed its trial data proved there was a reduction in medical visits in patients with the said COVID-19 severity.

The treatment involves monoclonal antibodies, casirivimab and imdevimab, and they have to be administered together.

Monoclonal antibodies are manufactured copies of antibodies that are created during a person's immune response to a virus.

It works by mimicking the immune system of a person to prevent severe illness from an infected patient, said a New York Post report.

As an "antibody cocktail," it has an antibody made by the company and another isolated from humans who recovered from the virus.

Using this combination, the spike protein of the coronavirus will be sought out and bound to the antibodies to stop it from infecting healthy human cells.

This kind of drug gained widespread attention have the president received it.

Trump was pleased with the effects of the Regeneron treatment, saying "I didn't feel good. A short 24 hours later, I was feeling great. I wanted to get out of the hospital. And that's what I want for everybody."

But while Trump said his health improved upon receiving the treatment from Regeneron, the company's CEO Dr. Leonard Schleifer said there is still more testing required.

Regeneron's Treatment to Help with Outpatients

FDA Commissioner Stephen Hahn said the agency is committed to "advancing the nation's public health during this unprecedented pandemic."

He added that with the approval of the antibody therapy, outpatients can avoid hospitalization and the healthcare system in the U.S. will bear lesser burdens.

Regeneron's antibody treatment is not the only one in development. A similar drug is being developed by Eli Lilly & Co. which also gained FDA clearance earlier this month.

It was also approved in helping newly infected cases or people who are at high risk of developing severe illness.

Officials said it can't be approved for hospitalized patients yet because the company's data did not show that the drug was effective during this stage of the disease.

With Regeneron's treatment approved, doctors had expanded the number of drugs at their disposal to fight the coronavirus.

Before it was FDA-approved, people could only get the treatment as part of an FDA program granting limited access to investigational medical products.