For immediate release:

Today, the US Food and Drug Administration issued an Emergency Use Approval (EUA) for casirivimab and imdevimab to be co-administered for the treatment of mild to moderate COVID-19 in adult and pediatric patients (12 years of age or older weighing at least 40 kg [about 88 pounds]) with positive results from direct SARS-CoV-2 viral tests and which have a high risk of developing severe COVID-19. This includes those who are 65 years or older or who have certain chronic medical conditions.

In a clinical trial in patients with COVID-1

9, casirivimab and imdevimab, co-administered, showed a reduction in COVID-19 related hospitalization or emergency visits in patients at high risk of disease progression within 28 days of placebo compared to placebo. The safety and efficacy of this in vitro COVID-19 therapy are still being evaluated.

Casirivimab and imdevimab should be co-administered by intravenous (IV) infusion.

Casirivimab and imdevimab are not approved for patients who are hospitalized due to COVID-19 or need oxygen therapy due to COVID-19. A benefit of casirivimab and imdevimab has not been shown in patients admitted with COVID-19. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with poorer clinical results when administered to hospitalized patients with COVID-19 requiring high-oxygen or mechanical ventilation.

“The FDA remains committed to promoting the country’s public health during this unprecedented pandemic. Approval of these monoclonal antibody therapies can help outpatients avoid hospitalization and alleviate the burden on our health care system, “said FDA Commissioner Stephen M. Hahn, MD. available to patients as soon as possible while continuing to investigate the safety and effectiveness of these treatments. ”

Monoclonal antibodies are laboratory-produced proteins that mimic the immune system’s ability to fight harmful pathogens such as viruses. Casirivimab and imdevimab are monoclonal antibodies specifically targeted to the spike protein of SARS-CoV-2, which are designed to block the attachment and entry of the virus into human cells.

“Emergency approval of these co-administered monoclonal antibodies provides healthcare providers with another tool to combat the pandemic,” said Patrizia Cavazzoni, MD, 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.”

The issuance of an EUA is different from an FDA approval. In assessing whether to issue an EUA, the FDA assesses the overall available scientific evidence and carefully weighs all known or potential risks with known or potential benefits of the product for use in an emergency. Based on the FDA’s review of the overall scientific evidence, the Agency has determined that it is reasonable to believe that casirivimab and imdevimab administered together may be effective in treating patients with mild or moderate COVID-19. When used to treat COVID-19 in the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks. There are no appropriate, approved and available alternative therapies for casirivimab and imdevimab co-administered to the authorized population.

The data supporting this EUA for casirivimab and imdevimab are based on a randomized, double-blind, placebo-controlled clinical trial of 799 non-hospitalized adults with mild to moderate COVID-19 symptoms. Of these patients, 266 received a single intravenous infusion of 2,400 mg casirivimab and imdevimab (1,200 mg each), 267 received 8,000 mg casirivimab and imdevimab (4,000 mg each), and 266 received placebo within three days of achieving a positive SARS. -CoV-2 viral test.

The pre-specified primary endpoint for the experiment was time-weighted mean change in viral load from baseline. The reduction in viral load in patients treated with casirivimab and imdevimab was greater than in patients treated with placebo on day seven. However, the main evidence that casirivimab and imdevimab co-administered can be effective came from the predefined secondary endpoint of COVID-19 medical visits, in particular hospitalizations and emergency visits within 28 days of treatment. For patients at high risk of disease progression, hospitalizations and emergency room visits occurred in 3% of casirivimab- and imdevimab-treated patients on average, compared with 9% in placebo-treated patients. The effects on viral load, reduction in hospitalizations and ER visits were similar in patients receiving one of the two doses of casirivimab and imdevimab.

According to the EUA, fact sheets providing important information on the use of casirivimab and imdevimab co-administered with COVID-19 as approved must be made available to healthcare providers and to patients and caregivers. These fact sheets include dosing instructions, potential side effects, and drug interactions. Possible side effects of casirivimab and imdevimab include: anaphylaxis and infusion-related reactions, fever, chills, hives, itching and redness.

EUA was issued to Regeneron Pharmaceuticals Inc.

The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of human and veterinary drugs, vaccines, and other biological products for human use and medical devices. The Agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and for the regulation of tobacco products.

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