- For immediate release:
Today, the U.S. The Food and Drug Administration (FDA) has issued Emergency Use Author (EUA) for the combined administration of Casirivimab and Imdevib for the treatment of mild to moderate COVID-19 in adult and pediatric patients (at least 40 years of age or 12 years of age or older). Is. Kilograms [about 88 pounds]) With positive results from a direct SARS-CoV-2 viral test and those who are at increased risk of progressing to severe SVID-19. This includes people who are 65 years of age or older or have a long medical condition.
In a clinical trial of patients with COVD-1, administered casirivimb and imdevib, when compared with placebo, patients at high risk for disease progression within 28 days after treatment were shown to be admitted to a civil-19-related hospital or reduce emergency room visits. . The safety and effectiveness of this probe treatment for use in the treatment of COVID-19 continues to be evaluated.
Cassirivimab and Imdeviv must be administered simultaneously by intervening (IV) inspiration.
C patients Sirivimab and Imdevimb are not authorized for patients who are hospitalized due to COVID-19 or in need of oxygen oxygen therapy due to COVID-19. The benefit of CDVimeb and imdevimeb treatment has not been shown in hospitalized patients due to COVID-19. Mozaclonal antibodies, such as cesirivimeb and imdevib, may be associated with poor clinical outcomes when hospitalized patients with COVID-19 are given high-flow oxygen or mechanical ventilation.
“The FDA is committed to advancing the country’s public health during this unprecedented epidemic. Authorizing these monoclonal antibody treatments could help outpatient hospitalization and relieve stress on our health care system, said FDA Commissioner Stephen M. “As part of our coronavirus treatment acceleration program, the FDA uses every possible means to create new treatments as quickly as possible for patients while studying the safety and effectiveness of these treatments,” said Han. ”
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight harmful pathogens, such as viruses. Casirivimeb and imdevimeb are monoclonal antibodies specifically directed against the spike protein of SARS-Covi-2, designed to block the attachment of the virus and its entry into human cells.
“The emergency authentication of these monoclonal antibodies administered together provides another tool for health disease providers to fight the epidemic,” said Patrizia Cavazoni, MD, MD, 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 EUA’s introduction differs from that of the FDA. In determining whether to submit to the EU, the FDA evaluates the completeness of the available scientific evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. Based on the FDA’s review of the completeness of the available scientific evidence, the agency has determined that it is reasonable to assume that co-administered casirivimb and imdevib may be effective in treating mild or moderate COVID-19 patients. When COVID-19 is used to treat the authorized population, the known and potential benefits of these antibodies outweigh the known and potential risks. There are not enough, valid and available alternative treatments for the authorized population to administer caserivim and imdevib together.
These EU-supported data for casirivimab and imdevimab are based on randomized, double-blind, placebo-controlled clinical trials in 799 non-hospitalized adults with mild to moderate COVD-19 symptoms. Of these patients, 266 patients received a single intravenous infusion of 2,400 mg of cesirivimeb and imdevib (1,200 mg each), 267 received 8000 mg of cesirivimab and imdevimb (4,000 mg each), and 266 received placebo for three days. Is inside. SARS-Cavi-2 viral test.
The predetermined primary end point for the trial was the time-weighted average change in viral load from baseline. The viral load reduction in patients treated with casirivimab and imdevimab was greater than in patients treated with placebo in seven days. However, the most important evidence that casirivimab and imdevimb can be administered together comes from the predefined secondary endpoint of COVID-19-related medical attendance visits, typically hospitalizations and visits to the emergency room within 28 days after treatment. For patients at high risk for disease progression, hospitalization and emergency room visits occur in the average place% of placebo-treated patients in cas% casirivimab and imdevimeb-treated patients. The effects on viral load, reduction in hospitalization, and ER visits were similar in patients receiving both casirivimeb and imdevimb doses.
Under the EU, fact sheets that provide important information about the use of CDVimab and Imdevimab, administered jointly as authorized for the treatment of KVID-19, must be made available to health care providers and patients and caregivers. These facts include dosing instructions, potential side effects, and drug interactions. Possible side effects of casirivimeb and imdevimeb include: anaphylaxis and reactions related to inspiration, fever, chills, hives, itching, and flushing.
The EU was issued to Regernon Pharmaceuticals Inc.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, 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, electronic radiation products, and the regulation of tobacco products.
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