For immediate release:

Today, the US Food and Drug Administration issued an Emergency Authorization (EUA) for kazirivimab and imdevimab to be used together to treat mild to moderate COVID-19 in adult and pediatric patients (aged 12 years or older at least 40 kilograms [about 88 pounds]) with positive results from direct viral testing for SARS-CoV-2 and who are at high risk of progression to severe COVID-19. This includes those who are 65 or older or who have certain chronic diseases.

In a clinical trial of patients with COVID-1

9, kazirivimab and imdevimab co-administered were shown to reduce hospitalizations or emergency department visits in patients at high risk of disease progression within 28 days of treatment compared with placebo. The safety and efficacy of this study therapy for use in the treatment of COVID-19 continue to be evaluated.

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

Cazirivimab and imdevimab are not approved for patients who are hospitalized for COVID-19 or require oxygen therapy for COVID-19. The benefit of treatment with kazirivimab and imdevimab has not been established in patients hospitalized for COVID-19. Monoclonal antibodies, such as kazirivimab and imdevimab, may be associated with poorer clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-speed oxygen or mechanical ventilation.

“The FDA remains committed to the development of the nation’s public health during this unprecedented pandemic. Allowing these monoclonal antibody therapies can help outpatients avoid hospitalization and alleviate the burden on our health system, “said FDA Commissioner Stephen M. Hahn, PhD.” As part of our program to accelerate coronavirus treatment. , The FDA uses all possible avenues to make new treatments available to patients as quickly as possible, while continuing to investigate the safety and effectiveness of these treatments. ”

Monoclonal antibodies are laboratory-made proteins that mimic the ability of the immune system to fight harmful pathogens such as viruses. Kazirivimab and imdevimab are monoclonal antibodies that are specifically directed against the SARS-CoV-2 spike protein, designed to block the attachment and entry of the virus into human cells.

“Urgently authorizing these monoclonal antibodies co-administered offers healthcare providers another tool to combat the pandemic,” said Dr. Patricia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. “We will continue to facilitate the development, evaluation and availability of therapies for COVID-19.”

EUA issuance is different from FDA approval. In determining whether to issue an EUA, the FDA evaluates the body of available scientific evidence and carefully balances all known or potential risks with known or potential benefits of the product for use during an emergency. Based on the FDA’s review of the body of available scientific evidence, the Agency has determined that it is reasonable to believe that kazirivimab and imdevimab co-administered may be effective in treating patients with mild to moderate COVID-19. When used to treat COVID-19 for the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks. There is no adequate, approved and available alternative treatment for kazirivimab and imdevimab co-administered to the authorized population.

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

The pre-specified primary endpoint for the test is the weighted average change in viral load from baseline. The reduction in viral load was greater in patients treated with kazirivimab and imdevimab than in patients treated with placebo on day 7. However, the most important evidence that kazirivimab and imdevimab co-administered can be effective comes from the pre-defined secondary endpoint of COVID-19-related medical visits, especially hospitalizations and emergency room visits within 28 days. after treatment. In patients at high risk of disease progression, hospitalizations and emergency department visits occurred in an average of 3% of patients treated with kazirivimab and imdevimab, compared with 9% of patients treated with placebo. The effects on viral load, reduced hospitalizations, and emergency visits were similar in patients receiving either dose of casirivib and imdevimab.

According to the EUA, information bulletins that provide important information on the use of kazirivimab and imdevimab co-administered in the treatment of COVID-19 as authorized should be provided to healthcare providers and patients and carers. These fact sheets include dosing instructions, potential side effects and drug interactions. Possible side effects of kazirivimab and imdevimab include: anaphylaxis and infusion-related reactions, fever, chills, urticaria, pruritus and redness.

The EUA is 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 supply of food, cosmetics, food additives, products that emit electronic radiation, and for the regulation of tobacco products.

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