FDA clears Regeneron's COVID-19 monoclonal antibody treatment and a home test

FDA has cleared the monoclonal antibody treatment for COVID-19 that President Donald Trump was treated with in October. The agency also gave the go-ahead late last week to the first home self-test for the pandemic disease.

The agency issued an emergency use authorization (EUA) for casirivimab and imdevimab (Regeneron) to treat mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kg.) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19.

Related: FDA grants emergency use for COVID-19 treatment

Earlier this month, FDA issued an EUA for the another monoclonal antibody therapy, bamlanivimab (Eli Lilly and Company), to treat mild-to-moderate COVID-19 in adult and pediatric patients.

“Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our healthcare system,” said FDA Commissioner Stephen M. Hahn, M.D., in a press release. “As part of our Coronavirus Treatment Acceleration Program, the FDA uses every possible pathway to make new treatments available to patients as quickly as possible while continuing to study the safety and effectiveness of these treatments.

In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together via IV infusion, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared with placebo.

However, FDA said that the combination therapy is not authorized for patients who are hospitalized with COVID-19 who require oxygen therapy because of the disease; in fact, the agency said the treatment might worsen the condition of such patients.

Related: U.S. government, AstraZeneca team up on COVID-19 preventative med

“A benefit of casirivimab and imdevimab treatment has not been shown in patients hospitalized due to COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation,” FDA said.

FDA also granted an EUA for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit (Lucira Health) is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19, the agency said in a press release.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” Hahn said.

The Lucira COVID-19 All-In-One Test Kit test, available by prescription only, is authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their healthcare provider.

It is also authorized for use in point-of-care (POC) settings such as doctor’s offices, hospitals, urgent care centers, and emergency rooms for all ages. However, samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old.

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