November 23, 2020 -- The FDA issued an emergency use authorization to Regeneron Pharmaceuticals for its monoclonal antibodies -- casirivimab and imdevimab -- to be given together to treat mild to moderate COVID-19 in adults and in kids over age 12.
The treatment should be given to patients who have a positive coronavirus test and face a high risk of getting severe COVID-19, including those who are 65 and older or have certain chronic medical conditions.
“Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system,” Stephen Hahn, MD, commissioner of the FDA, said in a statement.
Casirivimab and imdevimab must be given together through an IV. The lab-made proteins mimic the immune system and specifically target the spike protein on SARS-CoV-2, blocking the virus from entering human cells.
In a clinical trial of nearly 800 patients, the antibody treatment was shown to reduce COVID-19 hospitalizations and emergency room visits in patients who had a high risk of their disease getting worse. Within 28 days of treatment, 3% of people who took the treatment were hospitalized, compared with 9% of people who received the placebo.
The antibody combination is not authorized for patients who are hospitalized for COVID-19 or require oxygen. Clinical trials have not shown benefits for using the treatment in hospitalized patients, and in fact, it may lead to worse outcomes for those who need oxygen or ventilation, the FDA says. Possible side effects include a sudden allergic reaction called anaphylaxis and IV-related reactions, fever, chills, hives, itching, and skin reddening or blotching.
The experimental therapy was given to President Donald Trump when he contracted the coronavirus in October, according to CNBC. The FDA will continue to evaluate the safety and the results of the therapy for full approval.
Earlier this month, the FDA also authorized Eli Lilly’s antibody treatment -- called bamlanivimab -- for people who have COVID-19 and have a high risk of getting a severe form of the disease.
“The emergency authorization of these monoclonal antibodies administered together offers health care providers another tool in combating the pandemic,” Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.